Our commitment to people with muscle diseases
is our greatest strength

We are fearless innovators united by a shared mission: To bring transformative therapies to people living with serious muscle diseases. We pursue our goals with passion, determination, agility and urgency, recognizing that countless lives are depending on our efforts. We are here to forever change lives. We know we will deliver.

Our core values

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Delivering for patients

Our purpose

Transforming the futures of people living with serious muscle diseases.

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Dyne family

Our commitment

Acting with inclusion, transparency, respect, honesty and unity.

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One mission, no ego

Our vision

Driving boldly toward a shared mission, we’re stronger as one team.

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Embrace accountability to ensure excellence in execution

Our pledge

We do what we say we are going to do. What we do and how we do it defines success at Dyne.

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Fearless innovation

Our resolve

We push ourselves and one another to think bigger, act bolder, aim higher and to never fear failure.

We’re looking for colleagues who share this ethos to join the Dyne family. If you’re driven to deliver for people living with serious muscle diseases; if you put team and mission first; if you embrace bold ideas; if you are committed to accountability and transparency; if you have a drive to make a difference, we’d love to connect.

connect

Why we joined

Competitive benefits

Dyne offers our employees a competitive and comprehensive benefits package, which we believe is an important part of supporting the health and well-being of our employees and their families. These include:

  • Medical Insurance
  • Dental Insurance
  • Vision Insurance
  • Short & Long Term Disability
  • Life Insurance
  • Health Reimbursement Account
  • Flexible Spending Accounts
  • Dependent Care Spending Account
  • 401(k)
  • Flexible vacation, paid holidays, including one-week year-end office closure
Open positions

Interested in joining the Dyne team? See our open positions below. For more information or to apply, please contact us.

contact

Company Overview:

Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne’s broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

Role Summary:

We are seeking a talented and highly motivated Scientist to join Dyne’s Mechanistic Biology group in Waltham, MA. In this position, the candidate will plan and execute studies to evaluate the efficacy, pharmacodynamics, pharmacokinetics, and mechanisms of action of antibody-drug conjugates. The successful candidate will be able to work independently and provide scientific insight in support of drug discovery efforts. The ideal candidate has an innovative mindset and enjoys working in a collaborative and fast-paced laboratory setting.

Primary Responsibilities Include:

  • Execute and analyze in vitro and in vivo IND-enabling studies to characterize mechanisms of action and PK/PD profile of therapeutic candidates in relevant biological systems
  • Develop new assays to answer key muscle disease questions to ensure programs successfully progress the clinic
  • Contribute to the design and execution of assays to drive optimization of the FORCE™ platform
  • Work effectively with the bioconjugation and preclinical/exploratory safety teams to build the strongest possible data package for the nomination of clinical development candidates
  • Contribute to critical discussion of experimental design and assay development
  • Present results in a clear and concise manner to senior management
  • Contribute to building a positive culture of teamwork and scientific excellence
  • Document research efforts and maintain proper records

Education and Skills Requirements:

  • PhD in molecular biology, or related life sciences with 1-2 years of hands-on biotech/biopharma BSc/MSc with 5 or more years of relevant experience will also be considered
  • Ability to execute in vivo pharmacology studies with small rodents, including:
    • Dosing by several routes of administration
    • Tissue collection and processing for downstream assays
  • Hands-on experience with in vivo assays of skeletal muscle and neuromuscular function is highly desirable
  • Strong hands-on experience with standard molecular biology and histological techniques for the analysis of RNA and protein expression, including:
    • Nucleic acid extraction and gene expression analysis by qPCR or digital PCR
    • Protein isolation, subcellular fractionation, western blots, and ELISA
    • In-situ hybridization, immunohistochemistry, and immunofluorescence
  • Hands-on experience with standard histological protocols such as tissue-fixation, embedding and sectioning would be highly desirable
  • Experience working with CROs would be desirable
  • Effective written and oral communication skills, and ability to work efficiently in a fluid cross-functional research environment with limited supervision
  • Solid research track record with relevant publications and presentations
  • Proficiency in the use of software applications such as Prism, Excel, and PowerPoint

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Company Overview:

Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne’s broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

Role Summary:

The Associate Director of Oligonucleotide Synthesis will report to the Head of Platform Development and is responsible for leading oligo design, manufacturing and purification at Dyne.  S/he will manage internal and external oligo synthesis, analytics, and characterization of ASO and siRNA chemistries.  Candidate will be a subject matter expert in the understanding of testing, scale-up and cGMP manufacturing of nucleic acid drugs with a comprehensive understanding of oligo delivery and formulations.  S/he will collaborate closely with additional chemistry, biology, and research teams, supporting all stages of preclinical therapeutic development.  Candidate will use creative and proactive problem-solving strategies to progress oligo design and development in support of Dyne’s therapeutic pipeline.  S/he will act as an effective technical expert and work in a collaborative, constructive and mission-oriented focus for improving the lives of patients.

Education and Skills Requirements:

  • PhD in Chemistry, Biochemistry, or related discipline; with 8-10 years of relevant experience in drug discovery and development.
  • Strong practical knowledge of design, synthesis, and purification of nucleic acids.
  • Experience in scale-up manufacturing.
  • Excellent project, time management, and problem-solving skills.
  • Proven leadership and interpersonal skills, including ability to work across functional lines.
  • Ability to select and manage third-party vendors and collaborators, communicate technical information and work with all levels and functions within the Company.
  • Excellent written and verbal communication skills, including making effective and compelling presentations in both large and small groups and communicating complex scientific and nonscientific issues to program teams.
  • Ability to critically evaluate, summarize, interpret data.
  • Understand published scientific literature outside of his/her immediate area of expertise and appropriately apply this understanding to company aspects
  • Prepare manuscripts and other documents for publication and/or regulatory submission.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Company Overview:

Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne’s broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

Role Summary:

Dyne is seeking a talented and highly motivated Research Associate Scientist in analytical chemistry/biochemistry to help generate and advance our therapeutics research and support our drug discovery programs. In this role the candidate will be responsible for developing and running analytical assays to characterize a variety of research materials. S/He will collaborate closely with the platform group and colleagues across research to characterize therapeutic materials and will also have an opportunity to help establish and contribute to the operations of our laboratories.

The ideal candidate is a highly motivated individual with exceptional communication and collaboration skills. The qualified candidate will have the opportunity to build, contribute to, and expand our innovative platform technology and advance Dyne's mission of pioneering life-transforming therapies for patients with serious muscle diseases.

Primary Responsibilities Include:

  • Develop and perform qualitative/quantitative LC-MS and other analytical assays for the characterization of various research materials
  • Perform assays to analyze the stability, potency, purity and efficacy of therapeutic materials
  • Contribute to critical discussions of therapeutic structure, function and targets

Education, Knowledge & Skill Requirements:

  • BS or equivalent in biology/chemistry/biochemistry and 1-3 years of hands-on industry experience in drug discovery and development.
  • Experience with liquid chromatography (e.g., SEC, IEX, RP) and mass spectrometry techniques.
  • Broad experience with protein, oligonucleotide, and small molecule LC-MS analysis is a plus.
  • Strong organizational skills and attention to detail.
  • Ability to effectively communicate ideas and document research.
  • Experienced in software applications (Prism, Excel, PowerPoint).
  • Must be authorized to work in the United States
  • Position is based in Waltham, Ma; no relocation package available

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Company Overview:

Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne’s broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

Role Summary:

Dyne is seeking a talented and highly motivated Scientist in biology/chemistry/biochemistry to help generate and advance our therapeutics research and support our drug discovery programs. This team member will collaborate closely with in vitro/in vivo biology colleagues to generate and characterize research materials and will also help establish and contribute to the operations of our laboratories.

The ideal candidate is a highly motivated individual with exceptional communication and collaboration skills. The qualified candidate will have the opportunity to build, contribute to, and expand our innovative platform technology and advance Dyne's mission of pioneering life-transforming therapies for patients with serious muscle diseases.

Primary Responsibilities Include:

  • Execute research plans for the generation of research therapeutic candidates for in vitro and in vivo studies
  • Analyze the stability, potency, efficacy and purity of therapeutic materials
  • Develop in vitro systems for high-throughput screening of drug candidates
  • Identify and validate novel therapeutic targets to expand our FORCE platform
  • Contribute to critical discussions of therapeutic structure, activity, and function

 Education and Skills Requirements:

  • MS/PhD in biology/chemistry/biochemistry and 2-5 years of hands-on industry experience in early drug discovery and development
  • Experience in cell culture and in vitro cell-based assays (Flow Cytometry, Fluorescence Microscopy, ELISA, cell reporter systems)
  • Experience with high-throughput screening of candidate biologics or small molecules
  • Skills with chromatographic separation are a plus (e.g. SEC, HPLC, HIC, IEX, LC-MS)
  • Strong organizational skills and attention to detail
  • Ability to effectively communicate ideas and document research
  • Experienced in software applications (Prism, Excel, PowerPoint)
  • Must be authorized to work in the United States
  • Position is based in Waltham, MA; no relocation package available

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Company Overview:

Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne’s broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

Role Summary:

Reporting to the Vice President, Head of Preclinical Development (PCD), the Senior Director, Toxicology will be a key member of preclinical development teams and be responsible for the strategic planning and execution of nonclinical safety plans of Dyne’s portfolio programs supporting late discovery through first-in-human and proof-of-concept clinical studies of investigational antibody oligonucleotide therapeutics to treat serious muscle diseases. The candidate should possess an in-depth understanding of regulatory guidance as they pertain to the nonclinical development of novel therapeutics along with documented experience designing and critically evaluating results of exploratory and GLP-compliant toxicology studies. Previous experience in authoring and reviewing nonclinical regulatory documents as well as interactions with regulatory authorities is required. Additional responsibilities for candidates with the appropriate training in veterinary pathology include working with Research colleagues to evaluate in situ effects of lead candidates from pharmacology studies. The ideal candidate should have experience in the nonclinical safety assessment of therapeutic antibodies and/or oligonucleotides. The ability to work collaboratively with cross-functional teams is critical for this position.

Primary Responsibilities Include:

  • Represent PCD on program teams, providing expertise and guidance in regulatory toxicology
  • Design and execute nonclinical safety plans for Dyne candidate therapeutics
  • Principal contact to external CROs executing these studies, ensuring studies are conducted in line with the appropriate quality and regulatory standards and guidelines (FDA, CHMP, WHO and GLP)
  • Responsible for interpreting toxicology data and communicating results to program teams and senior management
  • Responsible for writing appropriate content and submission-ready documentation for the toxicology components of regulatory submissions
  • Lead issue-resolution teams, driving the science for investigative and discovery toxicology as needed
  • Additionally, pathologists would collaborate with Research colleagues in design of pharmacology / investigative studies to assess in situ effects of candidate molecules

Education and Skill Requirements:

  • PhD and post-doctoral training in toxicology or a related field and/or DVM
  • Relevant board certification
  • 8+ years of experience of nonclinical development experience in a biotech or pharmaceutical setting including direct experience in preparation of toxicology components of regulatory submissions
  • Experience in development of toxicology study package to ensure compliance with regulations
  • Experience designing and managing studies at contract research organizations
  • Experience writing and interpreting toxicology data, including the development of final reports
  • Experience in development of new supportive technologies or toxicological approaches
  • Experience assessing toxicity of antibody-drug conjugates is a plus
  • Expertise in immunology or immunotoxicology is a plus
  • Strong written and oral communication, organization and multitasking skills
  • Ability to work in a highly collaborative and cross-functional research environment including managing project timelines to meet corporate goals
  • Flexibility to function well within a team environment and within condensed timelines
  • Ability to verbalize complex study issues and demonstrated problem-solving ability

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Company Overview:

Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne’s broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

Role Summary:

Dyne is seeking an organized, detail and customer service-oriented Lab Manager to join our Lab Operations team. This team member will work with the Lab Operations Senior Manager to provide a smoothly operating laboratory for our scientific personnel. The successful candidate will be willing to learn, adapt and be able to perform at a high level in a fast-paced environment.

Primary Responsibilities Include:

  • Ensure that all laboratory equipment is properly functioning; coordinate preventative maintenance, repair, and purchase of equipment; maintain service contracts; coordinate training as needed
  • Oversee all aspects of EHS, including tracking/managing of chemicals and hazardous materials, enforcing PPE policy, assist with oversight and management of contract EHS and lab support, maintain permits, participate in and contribute to the IBC and Safety Committee
  • Coordinate with IT to ensure computers, data collection software and associated equipment are functioning in the lab
  • Work with Administrators to coordinate training for new lab personnel
  • Coordinate and support outgoing domestic and international shipments as needed
  • Must be willing to come in off hours to resolve lab emergencies if needed
  • Work with functional areas to generate standing orders and maintain managed inventories of consumables and reagents

Education, Knowledge & Skill Requirements: 

  • Bachelor’s degree in life science with 5+ years of experience in an industry BL2 wet lab.
  • Experience working with external vendors and service providers.
  • Ability to effectively prioritize, shift gears, and execute tasks based on business need.
  • Excellent decision making, communication and collaboration skills in a cross-functional and multi-level environment demonstrating very strong interpersonal skills
  • Experience with Electronic Notebook applications, LIMS, and databases
  • Ability to influence without authority and lead by example
  • Ability to self-evaluate work for accuracy and completeness
  • Experience with budget management, contract negotiation, and vendor management
  • Operational knowledge of and troubleshooting capabilities for common lab equipment
  • Takes initiative and exhibits independence in identifying and addressing short and long-term opportunities for optimization of lab processes
  • Current DOT and IATA certifications preferred
  • Must be able to lift 50 lbs. (this is the weight of one dry ice box) from the floor to approximately bench height
  • Must be able to sit, stand, walk, bend, stretch and don appropriate PPE for prolonged periods as needed

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Company Overview:

Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne’s broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

Role Summary:

The position will be responsible for product development, technology transfer and overall management of CMC activities related to the antibody ensuring robust development and reliable GMP supply of antibody drug conjugates and intermediates. Depending on the product phase, the Senior Director provides both guidance and active management of antibody in Phase 1 thru BLA and commercial production. This will include coordinating external development and manufacturing with contract development and manufacturing organizations (CDMOs), contract test labs (CTLs) and other external suppliers.   Another primary responsibility will the management of the clinical supply chain which includes integrated project management of all CMC vendors, shipping international and domestic, storage and clinical distribution, and management of drug product activities for clinical supply/   S/he will also have a matrix role for research and development activities related to antibody, bioconjugation and small molecule manufacturing.

This management role will report to the VP, CMC and will work closely with key stakeholders including Development, R&D, Clinical, Regulatory Affairs, Project Management, and corporate leadership to define and build the capabilities required to effectively manage Dyne’s complex clinical supply chain and support eventual launch and commercialization efforts.

Primary Responsibilities Include:

  • Responsible for all aspects of the antibody including process development, validation, characterization, scale-up, tech transfer, analytical method qualification, specifications, release and stability testing
  • Establish and manage contracts and supply agreements and manage CMOs
  • Oversees staff, suppliers and vendors involved in materials planning, inventory control, logistics, distribution to ensure that batch manufacturing is completed on a timely basis
  • Responsible for integrated project management of all CMC vendors ensuring all stakeholders support inventory required to fulfill research, pre-clinical and clinical needs
  • Responsible for storage and shipping of all pre-clinical and clinical intermediates, domestic and international
  • Oversee staff to set up a commercial supply chain prior to BLA
  • Responsible for drug product activities related to manufacture and clinical distribution
  • Work closely with R&D to support antibody and drug substance development activities and enhance the tech transfer process
  • Support QA compliance with cGMPs, cGLPs and guidance for clinical trial materials.
  • Prepare and review CMC documentation for biologic INDs and BLAs and support FDA and EMEA interactions
  • Supports the development of regulatory CMC documentation and partner due diligence.
  • Work with partner organizations as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any excursions, deviations, investigations, and CAPAs are initiated, addressed and closed within target timeframes
  • Provide patents and creative ideas to provide protection or creation of new or better products or processes

Education and Skill Requirements:

  • A minimum of 15 years in biopharmaceutical CMC management and/or Research & Development
  • Degree in biology, biochemistry, chemistry or similar related field required
  • Proven experience in processes and systems to support biopharmaceutical development
  • Experience leading contract manufacturing required. Experience with bioconjugates required
  • Strong knowledge of biologics and small molecules manufacturing, materials management, quality control, quality assurance and CMC regulatory requirements
  • Experience in all phases of CMC regulatory submissions and interactions regarding CMC issues, ideally including post-approval experience and international experience and negotiation experience with regulatory authorities on CMC issues related with biologic APIs
  • Excellent interpersonal, organizational, negotiations and communication skills; team member than can work collaboratively with colleagues across all functions
  • Results oriented: Establishes clear expectations and priorities, sets objectives and effectively applies resources. Sets clear goals and consistently delivers. Flexible and creative problem-solving skills.
  • Strategic Thinking: Can see the big picture, able to constantly think ahead about ways to do things better. Thinks logically, develops and evaluates options, identifies pros and cons. Able to challenge current processes, practices and strategy and uncover alternative approaches, solutions or methods.
  • Communications: Excellent communication and interpersonal skills with success in working across organizational boundaries at all levels to bring together people of diverse backgrounds and skill sets to create, influence and negotiate win-win solutions.
  • Strong interpersonal skills with the ability to motivate others, influence without authority, and negotiate conflict situations. Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
  • Self-directed: Individual who is able to work effectively with limited direction in a complex, fast-paced environment.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Company Overview:

Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne’s broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

Role Summary:

The Senior Manager of Clinical Quality Assurance (QA) will be responsible for leading GCP QA that provides QA support to clinical study teams. This leader will be skilled at building GCP processes and has in-depth knowledge of current GCP practices. This individual will be the subject matter expert in Good Clinical Practice (GCP), develop standards and partner with Clinical Operations, Regulatory, Biostatistics, Safety, Medical Affairs, and other functions to establish and document risk based GCP processes and procedures. This role will ensure compliance with applicable regulations with regards to sponsor oversight of Dyne’s clinical programs.

This role will report to the Senior Director of Quality Assurance and will work closely with key stakeholders including Clinical Development, Clinical Operations, Regulatory Affairs, and Project Management.

Primary Responsibilities Include:

  • Collaborate with manager and stakeholders to define and build the GCP QA capability designed to support Dyne’s clinical portfolio while maintaining a strong independent role for QA decision-making
  • Develop appropriate procedures and documentation to ensure standards, practices and policies and procedures are in compliance with applicable laws and regulations
  • Support the development and implementation of the QA vision, goals, core capabilities, and value while championing a strong Quality Culture
  • Provide GCP training
  • Manage domestic and international audits of sites, documents, databases, vendors, or internal systems in compliance with GCP and Dyne quality standards
  • Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks as needed. Ensure audit reports and corrective actions are developed and completed within mandated timelines
  • Assist project teams in implementing corrective and preventive actions; and enable teams to be inspection ready
  • Lead investigations into significant quality issues, scientific misconduct, and serious breach of GCP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness
  • Support the development of the Quality Management System framework for Clinical Operations
  • Establish and maintain Clinical Quality metrics. Present metrics and escalate systemic and/or critical problems to management
  • Proactively assess compliance issues and risks; serve as the expert GCP consultant for issue management & issue escalation, with a focus on critical and major quality events
  • Support investigational new drug applications and related correspondence from global regulatory authorities
  • Work with partner organizations as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any excursions, deviations, investigations, and CAPAs are initiated, addressed, and closed within target timeframes

Education and Skills Requirements:

  • GCP QA professional with broad drug experience which spans all clinical phases (Phase I to BLA/NDA)
  • Broad understanding of international regulations and guidance documents, with a focus on FDA & EMA regulations
  • A proven track record of demonstrating good judgement & decision-making experience
  • Excellent organizational skills
  • Ability to concisely present quality events and the criticality to internal stakeholders
  • Excellent interpersonal, verbal, and written communication skills with the ability to diplomatically address quality issues
  • Experience with GXP QA systems, processes, and procedures such as documentation and record management, change control, deviations, investigations, training, and CAPA
  • A working knowledge of the therapeutic area would be beneficial
  • Bachelor’s degree in a scientific discipline is required
  • 10+ years of relevant experience in a biotech/pharmaceutical setting including a GCP role
  • Results oriented, establishing clear expectations and priorities, sets objectives and effectively applies resources. Consistently delivers
  • Flexible and creative problem-solving skills; ability to challenge current processes, practices and strategy and uncover alternative approaches, solutions, or methods
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders and who is enthusiastic and willing to jump in to meet GMP as well as clinical compliance

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Company Overview:

Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne’s broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

Role Summary:

The position of Executive Assistant provides direct advanced administrative support to two company C-suite level executives and other members of their teams, as appropriate. This position will be responsible for managing multiple calendars, acting as the gatekeeper to protect the time of the executives as appropriate. This position will regularly interface with employees of all levels of the organization as well as key external partners.

Responsibilities Include but are not limited to:

  • Calendar management: responsible for meticulous calendar management, including planning meetings, coordinating recurring events and communicating with multiple parties to schedule large scale internal /external meetings
  • Travel management: arrange intricate domestic/international travel for VP (Executive?) including flights, trains, ground transportation and hotels and obtain travel visas as needed, work within company travel policies, and prepare relevant documentation and itinerary package and coordinate any real-time travel issues as they arise
  • Expense management: prepare, submit and track expense reports in a timely manner
  • Coordinate the Executives’ internal communications to staff, including Leadership Department and other meetings and communications
  • Engage with team members to prepare for upcoming meetings; producing and publishing agendas in advance of meetings
  • Order catering for meetings as needed
  • Set up conference rooms with audio, visual and conference calls when needed
  • Clarify expectations with team (e.g., due dates, meetings, information needed, etc.) and understand business priorities and challenges
  • Be available for occasional local travel, event, and meeting attendance as needed
  • Work closely and effectively with the Executives to be well informed of upcoming commitments and responsibilities, including key decisions, following up appropriately
  • Anticipate and solve challenges to ensure the most strategic use of the Executives’ time
  • Attend all team meetings, providing a summary of actions items to the Executives and team members as requested
  • Prioritize incoming communications (mail, email, calls) while anticipating and communicating any required actions/deadlines
  • Provide a bridge for effective and regular communication between the Executives and internal and external stakeholders; demonstrating leadership, collegiality and empathy to maintain credibility, trust and support.
  • Special projects as time permits

Education and Skills Requirements:

  • Experienced C-Suite Level executive assistant with experience in a high growth, fast paced corporate environment
  • High School Diploma is required, Bachelor’s degree is preferred
  • 10+ years’ experience as an Executive Assistant
  • Ability to recognize opportunities/gaps/obstacles, apply analytical and creative thinking to address issues or find innovative solutions and see them through to completion by taking ownership and accountability for meeting commitments and deadlines
  • Professional confidence in own ability and demonstrated intuition as a result of experience working through complex situations/issues
  • Demonstrated ability to work on multiple projects simultaneously leveraging strong organizational skills and flawless attention to detail, recognizing value and impact of the results
  • Prior experience in biotech/pharma preferred
  • Prior experience working with remote and hybrid teams in a matrixed organization
  • Strong Microsoft Suite proficiency (Word, Excel, Teams, PowerPoint, and Outlook)
  • Knowledge of teleconference equipment including Zoom, Teams, or other related software
  • Demonstrated experience managing multiple and complex travel arrangements while planning all aspects of complex meetings, on and off-site
  • Superior calendar management, organizational, time management and follow through skills to prioritize and coordinate workload with minimal supervision
  • Ability to determine how to handle calendar conflicts and decision making when organizing the executives’ time are vital to success in this position, including using the most effective means of communication (Live Meeting, Teleconferences, and Videoconferencing)
  • Interface with very senior level external partners and demonstrate high degree of professionalism and ability to handle confidential information in an appropriate manner
  • High degree of tact and discretion, highly professional and corporate presence, self-confidence, flexibility, and adaptability
  • Ability to effectively work in a fast-paced changing corporate environment is critical to success in the position
  • Ability to work well independently as well as in a team environment both with internal and external stakeholders
  • Demonstrate excellent judgment, initiative, reliability, accuracy, and problem solving
  • Demonstrate leadership and collaboration with other team members at all levels of the organization
  • Ability to identify, drive/coordinate independent projects to enhance learning curve and maximize contribution to fulfillment of corporate objectives
  • Dedication with initiative and ability to proactively identify needs without being asked
  • Ability to maintain composure and diplomacy when working under pressure, deadlines, and tenuous or ambiguous circumstances
  • Ability to remain focused in situations involving multiple interruptions
  • Ability to see the big picture, while maintaining excellent attention to details
  • Excellent verbal and written communication skills
  • Outstanding word processing and document preparation skills

To apply, please send your cover letter and CV to careers@dyne-tx.com

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Company Overview:

Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne’s broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

Role Summary:

The Sr. Director/VP, Clinical Development will serve as a key member of the Company’s leadership and will have primary responsibility for the design and oversight of an integrated development strategy, including both in-house development and potential strategic partnerships to augment the internally developed pipeline. This position will provide comprehensive leadership of the development process from pre-IND studies through to NDA and Phase IV programs. The Sr. Director/VP, Clinical Development will be responsible and accountable for the development of the medical aspects of the DM1 program. This role will be responsible for delivering quality and timely medical input and interpretation on specific program data in fulfilment of the DMI program objectives, working in partnership with regulatory affairs and pharmacovigilance in providing medical support for pharmacovigilance activities, responses to regulatory agency queries, and development.

Primary Responsibilities Include:

  • Lead the Clinical Development team across planning, design, development, and implementation of clinical trials for the DM1 drug candidate
  • Develop knowledge of disease mechanisms to select biomarkers, pharmacodynamic endpoints, and patient stratification considerations
  • Develop and implement an effective, timely and cost-efficient development program to establish the safety and efficacy of DM1 drug candidate compounds to achieve approval in the US and other countries
  • Develop protocols and study completion determinations
  • Coordinate with the discovery group to assure smooth transitioning of development candidates/programs from research into development
  • Provide pharmacovigilance oversight and manage timely reporting of safety signals to regulatory agencies
  • Guide Research team on decisions that have clinical components and implications
  • Identify, manage, and interface with external collaborators and key opinion leaders to create clinical development strategies for a novel class of therapeutics
  • Provide clinical development oversight for Discovery and Development programs, including strategy, planning, execution, and completion of clinical trials according to all applicable regulations and guidance
  • Collaborate with Clinical Operations to ensure all clinical study activities are completed in accordance with applicable regulations and guidance, maintaining the highest quality clinical programs, following GCP and ICH guidelines and the Company’s standard operating procedures
  • Select between outsourcing and in-house approaches for Clinical Development capabilities and work closely with the Clinical Operations team to implement choices
  • Manage relationships with third parties, such as CROs and outside collaborative partners, who are part of the DM1 clinical development efforts
  • Serve as medical representative to regulatory agencies, our investigators, and advisors and as study medical monitor, as needed
  • Participate as requested in Business Development due diligence and presentations to external constituencies
  • Manage the writing of protocols, presentations, and publications (regulatory submissions, original peer-reviewed articles, abstracts)
  • Review key documents including protocols, investigator brochures, and informed consent forms
  • Maintain accountability for all relevant timelines and deliverables working closely with functional counterparts and colleagues on the integration of product and clinical development plans
  • Manage, coordinate, and provide ongoing assessment, evaluation, and communication with other departments and external vendors in order to ensure study objectives and timelines are accomplished
  • Support the CMO with oversight and management of the department budget and financial planning
  • Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required
  • Ensure compliance with all applicable regulatory standards related to global clinical trials and interactions with physicians
  • Develop and implement SOPs for clinical trials and related activities, as required
  • Interface with departments within and outside of R&D including Finance, Regulatory Affairs, Legal, and Medical Affairs
  • Develop and maintain professional relationships with academic and community-based study sites
  • Represent the company in interactions with regulatory agencies
  • Provide leadership and mentorship to clinical development team members, managing matrix and direct line reports

Education and Skill Requirements:

  • Doctor of Medicine degree, PhD or Pharm. D., with a strong scientific background and a specialty in neurology or neuroscience training highly preferred
  • Minimum of 10 years of pharmaceutical industry experience
  • Experience leading a clinical development program(s) in Neurology/ Neuromuscular disorders
  • Experience with all aspects of designing, executing, monitoring, and managing clinical trials from inception to completion across all phases of development
  • Robust regulatory experience with Pre-INDs, INDs, CTAs, EOP 2 meetings and NDA/BLAs/MAA, both US and ex-US
  • Experience managing significant accelerations and challenges in clinical programs
  • Significant experience in communicating/presenting key/complex information to department/functional lead(s)/senior management
  • Strong knowledge of FDA and ICH regulations
  • Thorough knowledge of clinical medicine, clinical pharmacology and associated disciplines
  • Expert knowledge of Good Clinical Practice (GCP)
  • Experience in a small to mid-sized biotech company is preferred
  • Proven track record of drug development with Phase 1 through 3 trial experience preferred
  • Readiness to “roll up the sleeves” to contribute to team efforts
  • Excellent writing skills with a track record of publications and polished presentation skills to influence internal and external audiences
  • Ability to develop creative approaches to processes, practices, services, business models, and strategy
  • Ability to translate basic science into a product development plan that will maximize the product’s commercial opportunity
  • Ability to work successfully in a matrix environment and effectively build consensus
  • Communication skills (written and verbal), which are equally effective internally and externally, with large and small audiences, and one-on-one’s
  • Ability to effectively lead cross-functional meetings, and meetings with senior leaders to drive successful outcomes
  • Ability to create and inspire high-performance clinical development team
  • Ability to drive key actions at a high level of independence, working with staff, other senior leaders and designated external constituencies as necessary
  • Ability to effectively plan near to long-term strategy to ensure that most important efforts are prioritized and driven aggressively
  • Takes personal accountability for outcomes and thrives on increasing levels of responsibility to move the business forward
  • Strong project planning, leadership, negotiation, communication, and presentation skills as well as a demonstrated ability to contribute creative yet practical solutions to problems

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Company Overview:

Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne’s broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

Role Summary:

The Associate Director, Clinical Operations Trial Management will ensure that clinical strategies are translated into operational plans and executed in line with clinical development plans. This position will be responsible for initiating and leading clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives including aligning operational execution activities with agreed upon project priorities, timing, budget, and quality requirements. This position will ensure study conduct adheres to all relevant regulations including ICH GCP guidelines, local regulatory requirements, and Dyne’s policies and SOPs.

Responsibilities Include:

  • Manage all operational aspects from start-up to close-out activities of studies to assure adherence to timelines, budget and milestones while ensuring compliance applicable SOPs, guidelines and regulations
  • Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance
  • Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan
  • Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities
  • Support the selection, oversight, and management of CROs and other vendors
  • Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team
  • Manage clinical outsourcing to CROs and other vendors by conducting RFP and bid defense selection processes
  • Negotiate, review and execute CRO and vendor contracts/work orders and specifications to enable study objectives to be met
  • Monitor and assess vendor performance against contractual operational deliverables.
  • Drive performance, quality, timelines, and relationships in partnership with the CRO and other vendors
  • Provide oversight of study scope, quality, timelines and budget with the internal Dyne functional leads, CRO and vendors to ensure project objectives remain on track
  • Lead cross-functional teams and manage study team in partnership with the CRO
  • Participate in a site engagement program to builds solid professional relationships with key opinion leaders and clinical site staff to support clinical trial enrolment and other activities
  • Responsible for planning and conducting investigator meetings together with the CRO
  • Partner with the CRO to ensure patient enrollment strategies are carried out effectively and on time
  • Coordinate and participate in proactive data monitoring activities to ensure quality and completeness of study data
  • Evaluate issues, interpret data, and suggest and implement solutions and mitigation as required
  • Provide oversight of tracking of study activities (e.g., contracts, ICF, EC/IRB submissions, action/decision logs)
  • Create appropriate risk assessments and mitigation plans, perform regular reviews to continually assess changing circumstances
  • Proactively identify (e.g., performing trend review of protocol deviations, site action items, monitoring findings and EDC metrics) and resolve issues (e.g., managing through corrective and preventive action plans)
  • Author, review and approve various study related documents
  • Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
  • Review and approve essential document packages to enable timely site activations
  • Review pre-study, study initiation, interim monitoring visit and at study closeout visit reports
  • Provide close oversight on the findings on monitoring reports and follow up with broader team to provide updates
  • Direct investigator performance and adherence to protocol, and proactively address conduct issues and enrollment problems, as necessary
  • Perform co-monitoring and site visits where required
  • Provide ongoing oversight, maintenance and evaluate completeness of the TMF by performing periodic QC reviews to ensures the TMF and study is always “inspection ready”
  • Prepare high-quality reports (financial, project, etc.) for management on program status and issues as required
  • Provide management, oversight, coaching, mentoring, and development to team of direct and indirect reports supporting the clinical trials team and cross-functional teams

Education and Skills Requirements:

  • A. or B.S. in a scientific discipline; advanced degree desirable
  • Scientifically and clinically astute with very strong project management skills
  • Minimum of 5 years of clinical trial management experience in conducting Ph I-III International clinical trials in pharma/biotech organization
  • Prior experience managing, mentoring, coaching and developing team members including direct and indirect reports in a matrixed organization
  • Solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process, US/EU patient data privacy laws
  • Understand clinical study budgets, accruals and forecasting
  • Experience with clinical studies in muscular dystrophies desirable
  • Demonstrated ability to lead teams in a fast-paced matrixed environment, with the ability to manage and prioritize multiple tasks simultaneously
  • Understand technical, scientific and medical information, to plan, organize, project manage and analyze data
  • Enjoy building relationships with KOLs and site personnel with a willingness to travel to establish and build relationships
  • Experience in vendor selection and overseeing studies being managed by a CRO
  • Ability to successfully engage and work collaboratively with clinical operations team members/colleagues
  • Excellent interpersonal and decision-making skills
  • Demonstrated innovation, possesses drive, energy and enthusiasm to deliver the program objectives
  • Excellent planning, time management & coordination skills
  • Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
  • Experience in working in a small organization
  • Ability to travel for up to 25% is required (including overnight stays)
  • Excellent written and oral communication skills
  • Full competency in Microsoft Office programs

To apply, please send your cover letter and CV to careers@dyne-tx.com

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Company Overview:

Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne’s broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

Role Summary:

The Clinical Trial Manager will partner to execute the clinical trial strategy and inspection readiness activities, working closely with internal and external team members. Additional responsibilities may include study planning and execution; development of timelines and budget; and vendor management. This role requires strong organizational skills, and strong knowledge of FDA and local  regulatory requirements, as well as and Dyne’s policies and SOPs, to ensure trial(s) are managed to the highest level of quality.

Primary Responsibilities Include:

  • Assist with all operational aspects from start-up to close-out activities of studies to assure adherence to timelines, budget and milestones while ensuring compliance applicable SOPs, guidelines and regulations
  • Partner to maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance
  • Execute operational strategy and clinical operations plans in support of execution of the Clinical Development Plan
  • Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities
  • Support the selection, oversight, and management of CROs and other vendors
  • Support oversight of site feasibility/capability assessments in collaboration with the CRO and cross-functional team
  • Assist with managing clinical outsourcing to CROs and other vendors by conducting RFP and bid defense selection processes
  • Partner to negotiate, review and execute CRO and vendor contracts/work orders and specifications to enable study objectives to be met
  • Monitor and assess vendor performance against contractual operational deliverables.
  • Help to drive performance, quality, timelines, and relationships in partnership with the CRO and other vendors
  • Assist in providing oversight of study scope, quality, timelines and budget with the internal Dyne functional leads, CRO and vendors to ensure project objectives remain on track
  • Participate in cross-functional teams and manage study team in partnership with the CRO
  • Participate in a site engagement program to builds solid professional relationships with key opinion leaders and clinical site staff to support clinical trial enrolment and other activities
  • Assist in planning and conducting investigator meetings together with the CRO
  • Partner with the CRO to ensure patient enrollment strategies are carried out effectively and on time
  • Help to coordinate and participate in proactive data monitoring activities to ensure quality and completeness of study data
  • Evaluate issues, interpret data, and suggest and implement solutions and mitigation as required
  • Help to provide oversight of tracking of study activities (e.g., contracts, ICF, EC/IRB submissions, action/decision logs)
  • Help to create appropriate risk assessments and mitigation plans, perform regular reviews to continually assess changing circumstances
  • Proactively identify (e.g., performing trend review of protocol deviations, site action items, monitoring findings and EDC metrics) and resolve issues (e.g., managing through corrective and preventive action plans)
  • Assist in authoring and reviewing various study related documents
  • Help to review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
  • Review pre-study, study initiation, interim monitoring visit and at study closeout visit reports
  • Assist to provide close oversight on the findings on monitoring reports and follow up with broader team to provide updates
  • Help to direct investigator performance and adherence to protocol, and proactively address conduct issues and enrollment problems, as necessary
  • Perform co-monitoring and site visits where required
  • Assist in providing ongoing oversight, maintenance and evaluate completeness of the TMF by performing periodic QC reviews to ensures the TMF and study is always “inspection ready”
  • Prepare high-quality reports (financial, project, etc.) for management on program status and issues as required

Education and Skills Requirements:

  • A. or B.S. in a scientific discipline; advanced degree desirable
  • Scientifically and clinically astute with very strong project management skills
  • Minimum of 3-5 years of clinical trial management experience in conducting Ph I-III International clinical trials in pharma/biotech organization
  • Solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process, US/EU patient data privacy laws
  • Understand clinical study budgets, accruals and forecasting
  • Experience with clinical studies in muscular dystrophies desirable
  • Demonstrated ability to lead teams in a fast-paced matrixed environment, with the ability to manage and prioritize multiple tasks simultaneously
  • Understand technical, scientific and medical information, to plan, organize, project manage and analyze data
  • Enjoy building relationships with KOLs and site personnel with a willingness to travel to establish and build relationships
  • Experience in vendor selection and overseeing studies being managed by a CRO
  • Ability to successfully engage and work collaboratively with clinical operations team members/colleagues
  • Excellent interpersonal and decision-making skills
  • Demonstrated innovation, possesses drive, energy and enthusiasm to deliver the program objectives
  • Excellent planning, time management & coordination skills
  • Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
  • Experience in working in a small organization
  • Ability to travel for up to 25% is required (including overnight stays)
  • Excellent written and oral communication skills
  • Full competency in Microsoft Office programs

To apply, please send your cover letter and CV to careers@dyne-tx.com

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Company Overview:

Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne’s broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

Role Summary:

Dyne is seeking an experienced clinical operations leader for the newly created role of Vice President, Clinical Operations, accountable for the resourcing, development, training, and management of a highly performing clinical operations team, and strategic oversight and execution (within budget and timelines) of clinical plans. A successful candidate must thrive in a fast-paced environment where flexibility, accountability, and teamwork are paramount, and share a passion for Dyne’s mission to bring transformative therapies to people living with serious muscle diseases. Additionally, this individual must have excellent interpersonal skills and be able to analyze complex issues to develop strategies to successfully implement clinical trial plans. This position reports to the Senior Vice President, Clinical Development.

Primary Responsibilities Include:

  • Provide strategic operational guidance to ensure that trials are properly defined, planned, and executed to a high degree of quality across all clinical stage programs.
  • Develop and implement a clinical vendor oversight process with documentation to record transfer of regulatory responsibilities, evaluation of performance, and escalation of issues.
  • Establish, implement, and proactively manage clinical trial processes, strategic outsourcing, and performance indicators.
  • Ensure high standards for compliance and quality within the Clinical Operations team and across clinical trial vendors with company SOPs, ICH-GCP guidelines that govern regulations, and patient safety standards.
  • Regularly report clinical trial status, identify challenges and program/resource gaps, and devise and implements solutions.
  • Provide strategic input to clinical-trial related risk analysis and mitigation strategies.
  • Provide operations input into trial-related documentation and regulatory submissions.
  • Lead the development and review of clinical program budgets, and track and forecast spend for initiated studies.
  • Lead authorship of Clinical Operations SOPs and other function-specific documentation.
  • Recruit, mentor and develop Clinical Operations staff.

Education and Skill Requirements:

  • BS/BA in a scientific discipline with at least 20 years of relevant clinical operations experience; or, MS or PhD in a scientific discipline and 15 years of relevant clinical operations experience.
  • Previous Clinical Operations functional and/or program leadership, including hiring and managing Clinical Operations staff, selecting and managing vendors/CROs, and optimizing resources across clinical studies.
  • Experience implementing clinical trial management systems, including TMF, EDC, IXRS.
  • Experience running global clinical trials from initial feasibility through to CSR delivery.
  • Detailed knowledge of clinical research practices, FDA/EMA regulations and ICH GCP Guidelines regarding drug development in all phases, and data management methods.
  • Familiarity with European GDPR legislation and managing emerging impact on clinical trial conduct.
  • Experience running trials in rare disease preferred.
  • NDA/BLA regulatory filing experience preferred.
  • Excellent communication and presentation skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Company Overview:

Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne’s broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

Role Summary:

Reporting to the Vice President, Head of Regulatory, the Medical Writer will support development teams and be primarily responsible for writing and overseeing various clinical and regulatory documents. This position interacts with other functions (e.g., clinical development, clinical operations, clinical pharmacology, research, preclinical, biomarkers, program management, and medical affairs). This person will work ensure the documents are of high quality and completed in a timely fashion compliant with SOPs, ICH/GCP/regulatory guidelines, and company goals. The Medical Writer will lead efforts to author documents including protocols, Investigator’s Brochures, annual reports, clinical study reports, regulatory briefing documents, and clinical sections of regulatory submissions (IMPDs, INDs, and CTAs). Some authoring of nonclinical documents may be included.

Previous experience in authoring and reviewing clinical and regulatory documents is desired. The ability to lead strategic discussions to ensure aligned messaging throughout regulatory documentation is critical.  Outstanding communication skills are a must.

Primary Responsibilities Include:

  • Write, edit, or collaborate with program team members on a variety of regulatory documents including protocols, investigator brochures, clinical study reports, INDs, and briefing books
  • Ensure efficient document management as well as a consistent style of presentation to maintain quality and ease of review across multiple documents assembled in a regulatory dossier
  • Review, edit, and ensure quality of documents or sections of documents prepared by functional area representatives as required and ensure adherence to standards
  • Oversee document review roundtables and comment adjudication meetings
  • Contribute to overall project management and to cross functional working groups as needed to facilitate efficient development and finalization of clinical, nonclinical and regulatory documents for submissions
  • Develop best practices for authoring and reviewing
  • Manage external writing staff as directed

Education and Skill Requirements:

  • Bachelors degree or high in Life Sciences, with a solid understanding of the basic principles of biochemistry and molecular biology
  • At least 5 years of experience writing clinical/regulatory documents for a pharmaceutical or biotechnology company is required
  • Demonstrates competence in writing, editing, and reviewing protocols, clinical study reports, investigator brochures, registration dossier modules, and other clinical regulatory documents per company and other guidelines
  • Understands of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs).
  • Demonstrates technical expertise in typical office Applications (e.g., Microsoft Office, Adobe Acrobat) and in shared document systems (e.g., SharePoint)
  • Well-organized: ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high quality documents according to tight timelines
  • Detailed knowledge of requirements for preparation of key clinical, nonclinical and regulatory documents for INDs, CTAs, and annual reports
  • Accurate and detail-oriented
  • Aptitude for compilation, analysis, and presentation of data
  • Independently motivated, and good problem-solving ability
  • Ability to work with multiple contributors to produce a final unified document

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Company Overview:

Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne’s broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

Role Summary:

The Director, Regulatory Affairs will help drive forward our regulatory strategy and operational activities related to Dyne’s muscle disease programs.  A successful candidate must thrive working in a fast-paced environment where flexibility, accountability and fearless innovation are key. Additionally, this individual must have excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic regulatory and strategies. A shared passion for Dyne’s mission to bring transformative therapies to people living with serious muscle diseases is a must.

Primary Responsibilities Include:

  • Interact with other departments to develop regulatory strategy and submission plans for quality and timely filings.
  • As a member of program teams, provide global regulatory guidance regarding requirements for clinical development and registration of pharmaceuticals.
  • Oversee preparation, review and submission of regulatory documents maintaining compliance with regulatory requirements.
  • Manage timelines and preparation of meeting requests and briefing documents.
  • Author/edit documents to support regulatory submissions.
  • Compile, review, approve and submit clinical trial and marketing registration applications, amendments, and supplements.
  • Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
  • Support the organization with health authority meetings.
  • Provide strategic guidance for and author applications related to expedited programs/designations for rare muscle disease (e.g. Fast Track, Orphan Drug Designation, etc.).
  • Manage staff and vendors as needed to support regulatory activities.
  • Assist with SOP generation.
  • Perform other duties as required, interfacing with other departments, CROs and external vendors as needed

Education, Knowledge & Skill Requirements:

  • Minimum of a bachelor’s degree in life science or related discipline is required
  • Minimum of 5-8 years of experience in regulatory strategy [in a clinical-stage biotechnology company]
  • Strong experience with CTD format and content regulatory filings
  • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
  • Experience in Health Authority Meetings
  • Knowledge of EU and international regulations related to the clinical, nonclinical, and CMC development a plus
  • Ability to work independently to manage multiple projects in a fast-paced environment
  • Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestones
  • Effectively communicate the regulatory strategy, risks, mitigations, and overall plans to Project Teams and senior management
  • Outstanding communication skills (verbal and written), regulatory writing skills and willingness to share knowledge and lessons learned

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Company Overview:

Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne’s broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

Role Summary:

Dyne is seeking an experienced clinical operations leader for the newly created role of Vice President, Clinical Operations, accountable for the resourcing, development, training, and management of a highly performing clinical operations team, and strategic oversight and execution (within budget and timelines) of clinical plans. A successful candidate must thrive in a fast-paced environment where flexibility, accountability, and teamwork are paramount, and share a passion for Dyne’s mission to bring transformative therapies to people living with serious muscle diseases. Additionally, this individual must have excellent interpersonal skills and be able to analyze complex issues to develop strategies to successfully implement clinical trial plans. This position reports to the Senior Vice President, Clinical Development.

Primary Responsibilities Include:

  • Provide strategic operational guidance to ensure that trials are properly defined, planned, and executed to a high degree of quality across all clinical stage programs.
  • Develop and implement a clinical vendor oversight process with documentation to record transfer of regulatory responsibilities, evaluation of performance, and escalation of issues.
  • Establish, implement, and proactively manage clinical trial processes, strategic outsourcing, and performance indicators.
  • Ensure high standards for compliance and quality within the Clinical Operations team and across clinical trial vendors with company SOPs, ICH-GCP guidelines that govern regulations, and patient safety standards.
  • Regularly report clinical trial status, identify challenges and program/resource gaps, and devise and implements solutions.
  • Provide strategic input to clinical-trial related risk analysis and mitigation strategies.
  • Provide operations input into trial-related documentation and regulatory submissions.
  • Lead the development and review of clinical program budgets, and track and forecast spend for initiated studies.
  • Lead authorship of Clinical Operations SOPs and other function-specific documentation.
  • Recruit, mentor and develop Clinical Operations staff.

Education and Skill Requirements:

  • BS/BA in a scientific discipline with at least 20 years of relevant clinical operations experience; or, MS or PhD in a scientific discipline and 15 years of relevant clinical operations experience.
  • Previous Clinical Operations functional and/or program leadership, including hiring and managing Clinical Operations staff, selecting and managing vendors/CROs, and optimizing resources across clinical studies.
  • Experience implementing clinical trial management systems, including TMF, EDC, IXRS.
  • Experience running global clinical trials from initial feasibility through to CSR delivery.
  • Detailed knowledge of clinical research practices, FDA/EMA regulations and ICH GCP Guidelines regarding drug development in all phases, and data management methods.
  • Familiarity with European GDPR legislation and managing emerging impact on clinical trial conduct.
  • Experience running trials in rare disease preferred.
  • NDA/BLA regulatory filing experience preferred.
  • Excellent communication and presentation skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Company Overview:

Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne’s broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

Role Summary:

Dyne Therapeutics is looking for a strategic leader to define the IT architecture and systems as the organization moves into a rapid growth phase. The opportunity for the ideal candidate will be to shape the future of technology at Dyne while ensuring the organization is built for security and scale.

Dyne Therapeutics is seeking a Director of IT to support our business as it grows into a clinical stage biotech company and prepares for a transition to a commercialized business. The ideal candidate will have 10+ years of experience with a solid understanding of Information Technology and cGXP best practices with 5+ years of computer system validation (CSV) experience in an FDA regulated industry. Areas of focus will be implementation of validated computer systems, system design, IT Architecture, workflow development, project management and desktop support. This position will be responsible for implementing and maintaining ITGC and IT SOX controls and responsible for maintaining a stable, qualified, and highly available computing infrastructure and implementation and validated computer systems. Candidates should demonstrate initiative and ability to navigate ambiguity and a willingness to grow as the company scales in size.

This is a full-time position based in Waltham, MA and reports directly to the VP, Finance.

Primary Responsibilities Include:

IT Architecture

  • Refine the current IT design and improve for scale
  • Lead the design and implementation of IT infrastructure at Dyne’s new offices
  • Create a scalable architecture including cloud and on-premise solutions

IT Business Management

  • Implement and manage security and compliance controls including strong vendor management
  • Build and implement a multi-year scalable IT strategy and vision for the company across functions
  • Provide thought leadership in architecting business applications and define an enterprise-wide integration vision and strategy for all business applications
  • Partner with the Finance organization to facilitate the department’s forecasting process and ensure conformance to IT operating expense budget
  • Partner with Quality Assurance and business system owners across the organization to ensure GxP computerized systems are operating effectively, efficiently, and in compliance US GxP regulations and EU guidelines
  • Educate, coach, mentor and train the IT stakeholders and cost center owners on best practices and methodologies
  • Be autonomous in decision making, but collaborate when needing to escalate to senior leadership team
  • Serve as the single point of contact for all implemented software across the company

IT Vendor Management

  • Responsible for managing relationships with specific vendors and serving as the IT organization's point of contact
  • Review vendor contracts and analyze proposals and quotes; review and process vendor Statements of Work and assist with creation of capital asset requests
  • Support the facilitation of strategic vendor business reviews; research, interview and negotiate with vendors to obtain prices and specifications
  • Conduct periodic review of software/hardware maintenance contract renewals and proactively contact vendors for quotes and submit purchase requisitions
  • Proactively identify process improvements and help find efficient solutions

User Support

  • Provide on-site expertise and technical knowledge of laptops, printers, and mobile computing devices
  • Arrange end user on-boarding, off-boarding, provisioning, and de-provisioning
  • Provide support for conference rooms

Knowledge & Skills

  • Knowledge of regulatory compliance including SEC, SOX, CFR Pt.11, EU Annex 11, cGxP, HIPAA, PDMA, GDPR and support to commercialization
  • Experience supporting all levels including C-suite executives, partnering with senior leaders to identify needs and implement scalable capabilities to support their functional goals, as well as global regulatory filings
  • Solid knowledge of vendor management and technology business management processes and methodologies
  • Experience with software development life cycle in regulated environment
  • Strong facilitation skills and ability to influence and negotiate positive outcomes
  • Excellent communication skills (verbal, written, presentation) and ability to communicate well with all stakeholders and teams in person, over the phone and via email
  • Able to work both independently and in a team-oriented, collaborative environment
  • Ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities
  • Effective influencing and negotiating skills in an environment with cross functional teams, contractors, resources, and third-party vendors
  • Understanding of Identity based security solutions
  • Cybersecurity certification preferred
  • Experience with cloud technologies such as AWS, Azure
  • Experience with Microsoft 365, cloud support, and experience in transitioning and implementing MS SharePoint

Education & Experience:

  • Bachelor's degree or equivalent experience in technology or related field
  • Ten plus (10+) years related experience
  • Experience in biotech highly desirable
  • Three (3) years of Budget and Vendor management domain experience preferred
  • Expertise in both PC and MAC environments
  • Working knowledge of HIPAA, Sarbanes-Oxley, FDA, GDPR compliance
  • Experience working in a SOX environment and working with external auditors

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Company Overview:

Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne’s broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

Role Summary:

Dyne Therapeutics is looking for a strategic leader to define the IT architecture and systems as the organization moves into a rapid growth phase. The opportunity for the ideal candidate will be to shape the future of technology at Dyne while ensuring the organization is built for security and scale.

Dyne Therapeutics is seeking a Director of IT to support our business as it grows into a clinical stage biotech company and prepares for a transition to a commercialized business. The ideal candidate will have 10+ years of experience with a solid understanding of Information Technology and cGXP best practices with 5+ years of computer system validation (CSV) experience in an FDA regulated industry. Areas of focus will be implementation of validated computer systems, system design, IT Architecture, workflow development, project management and desktop support. This position will be responsible for implementing and maintaining ITGC and IT SOX controls and responsible for maintaining a stable, qualified, and highly available computing infrastructure and implementation and validated computer systems. Candidates should demonstrate initiative and ability to navigate ambiguity and a willingness to grow as the company scales in size.

This is a full-time position based in Waltham, MA and reports directly to the VP, Finance.

Primary Responsibilities Include:

IT Architecture

    • Refine the current IT design and improve for scale
    • Lead the design and implementation of IT infrastructure at Dyne’s new offices
    • Create a scalable architecture including cloud and on-premise solutions

IT Business Management

    • Implement and manage security and compliance controls including strong vendor management
    • Build and implement a multi-year scalable IT strategy and vision for the company across functions
    • Provide thought leadership in architecting business applications and define an enterprise-wide integration vision and strategy for all business applications
    • Partner with the Finance organization to facilitate the department’s forecasting process and ensure conformance to IT operating expense budget
    • Partner with Quality Assurance and business system owners across the organization to ensure GxP computerized systems are operating effectively, efficiently, and in compliance US GxP regulations and EU guidelines
    • Educate, coach, mentor and train the IT stakeholders and cost center owners on best practices and methodologies
    • Be autonomous in decision making, but collaborate when needing to escalate to senior leadership team
    • Serve as the single point of contact for all implemented software across the company

IT Vendor Management

    • Responsible for managing relationships with specific vendors and serving as the IT organization's point of contact
    • Review vendor contracts and analyze proposals and quotes; review and process vendor Statements of Work and assist with creation of capital asset requests
    • Support the facilitation of strategic vendor business reviews; research, interview and negotiate with vendors to obtain prices and specifications
    • Conduct periodic review of software/hardware maintenance contract renewals and proactively contact vendors for quotes and submit purchase requisitions
    • Proactively identify process improvements and help find efficient solutions

User Support

    • Provide on-site expertise and technical knowledge of laptops, printers, and mobile computing devices
    • Arrange end user on-boarding, off-boarding, provisioning, and de-provisioning
    • Provide support for conference rooms

Knowledge & Skills:

  • Knowledge of regulatory compliance including SEC, SOX, CFR Pt.11, EU Annex 11, cGxP, HIPAA, PDMA, GDPR and support to commercialization
  • Experience supporting all levels including C-suite executives, partnering with senior leaders to identify needs and implement scalable capabilities to support their functional goals, as well as global regulatory filings
  • Solid knowledge of vendor management and technology business management processes and methodologies
  • Experience with software development life cycle in regulated environment
  • Strong facilitation skills and ability to influence and negotiate positive outcomes
  • Excellent communication skills (verbal, written, presentation) and ability to communicate well with all stakeholders and teams in person, over the phone and via email
  • Able to work both independently and in a team-oriented, collaborative environment
  • Ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities
  • Effective influencing and negotiating skills in an environment with cross functional teams, contractors, resources, and third-party vendors
  • Understanding of Identity based security solutions
  • Cybersecurity certification preferred
  • Experience with cloud technologies such as AWS, Azure
  • Experience with Microsoft 365, cloud support, and experience in transitioning and implementing MS SharePoint

Education & Experience:

  • Bachelor's degree or equivalent experience in technology or related field
  • Ten plus (10+) years related experience
  • Experience in biotech highly desirable
  • Three (3) years of Budget and Vendor management domain experience preferred
  • Expertise in both PC and MAC environments
  • Working knowledge of HIPAA, Sarbanes-Oxley, FDA, GDPR compliance
  • Experience working in a SOX environment and working with external auditors

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.