Our commitment to people with muscle diseases
is our greatest strength

Study Coordinator, Preclinical Development Outsourcing

Department: 104 Non-Clinical

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:

This role will be a key member of Preclinical Development (PCD) function supporting the strategic planning and implementation of outsourced studies for the General Toxicology and Pharmacokinetics/Pharmacodynamics (PK/PD) groups. Working closely with Study Program Leads, Finance, Regulatory and Project Management as well as other departments, the successful candidate will be expected to provide expertise / support in; updating study timelines, maintaining accurate financials and communications with Contract Research Organizations (CRO).  The incumbent will also work closely with outsourcing leadership to apply various approaches and strategies to maintain and expand a user friendly and innovative outsourcing program adaptable to change.

This role is based in Waltham, MA without the possibility of being a remote role. 

Primary Responsibilities Include:

  • Collaborate closely within Preclinical Teams supporting outsourced studies and Contract Research Organization (CRO) partners to actively manage and monitor progress of multiple research projects towards timely milestone achievements 
  • Align with CRO and Dyne teams on design and timing of studies needed to support various programs
  • Support financial aspect of outsourced studies via contract processing, purchase order generation, processing of timely/accurate invoice payments and support for budget forecasting
  • Request cost estimates and Statements of Work (SOW) contracts for individual studies from CROs and work with various Dyne Teams to schedule studies to meet program timelines 
  • Work closely with relevant Dyne colleagues and CROs to coordinate and track all study-related documentation, specimen shipment, reporting timelines and archiving by maintaining appropriate file management and document control for assigned programs including timely delivery of reports in various stages leading to Final Report.
  • Maintain study tracking sheets and study calendars to ensure correct information is available for Dyne Teams to reference
  • Support implementation of new procedures by creating user friendly templates and rolling out to target audience 

Education and Skill Requirements:

  • B.S. / B.A. in Biology, General Studies or a related field
  • At least 2 years of experience in a pharmaceutical company
  • Previous experience as a Study Coordinator/Project Manager desirable
  • Excellent communication skills with team player attitude
  • Ability to complete assigned tasks independently and in a timely manner
  • Strong understanding of Microsoft Office programs
  • Aptitude for organizational detail, change agility and ability to manage multiple projects concurrently
  • Ability to function / support project(s) needs in a team environment under demanding timelines
  • Comfortable verbalizing complex study issues along with 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.


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