Our commitment to people with muscle diseases
is our greatest strength

Associate Director, Clinical Operations Trial Management

Department: 121 Clinical Operations

Location: Waltham, MA

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.

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