Our commitment to people with muscle diseases
is our greatest strength

Senior Director, Clinical Pharmacology and Pharmacometrics

Department: 120 Clinical Development

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 Senior Director,Clinical Pharmacology and Pharmacometrics will report to the Vice President, Head of Preclinical Development (PCD) and is responsible for establishing and leading a Clinical Pharmacology and Pharmacometrics discipline at Dyne Therapeutics. Primary responsibilities include building and leading a team of Clinical Pharmacology and ADME-PK scientists, strategic planning and execution of clinical pharmacology and modeling and simulation (M&S) activities as a core member of program teams, and leading collaborations with cross-functional leaders in Dyne as well as external partners. The ideal candidate will have a strong knowledge of best practices in Clinical Pharmacology and Pharmacometrics, extensive experience in designing and executing clinical pharmacology studies, and a demonstrated ability to make data-driven decisions based on preclinical and clinical information. The person will also work very closely with team members in the bioanalytics and biomarkers function. As a core member of cross-functional program teams the selected candidate will work in close collaboration with colleagues in discovery, research, clinical development, clinical operations, and project management contributing to multiple IND submissions, initiation of clinical development programs, late-stage development, and interactions with health authorities.

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

Primary Responsibilities Include:

  • Lead the Clinical Pharmacology function and strategy, with a vision to create scientifically sound, innovative, and efficient programs that meet regulatory requirements, as well as corporate and R&D program goals, enabling advancement of Dyne programs across all stages of drug development
  • Represent PCD as subject matter expert (SME) providing expertise and guidance on PK/PD and clinical pharmacology on discovery and program teams
  • Identify and manage consultants and vendors to support clinical pharmacology and M&S activities
  • Build and develop quantitative tools to translate PK/PD relationship from preclinical to clinical using M&S
  • Author high quality regulatory documents
  • Accountable for adherence to agreed timelines and budgets to ensure execution of deliverables from Clinical Pharmacology studies and programs
  • Collaborate cross functionally with all relevant areas to support corporate objectives

Education and Skill Requirements:

  • PhD, PharmD, or equivalent training in pharmacokinetics, pharmaceutical sciences, or related disciplines with at least 10 years of bio/pharmaceutical industry drug development experience in Clinical Pharmacology
  • Strong understanding of Clinical Pharmacology principles, PK/PD modeling and simulation, the drug development process, and regulatory guidance to support Clinical Pharmacology strategies
  • Experience with the preparation of Clinical Pharmacology portions of regulatory documents such as the pre-IND, IND, IB, briefing documents, clinical study reports, CTA, and BLA
  • Hands-on skills in M&S using Phoenix/WinNonlin, NONMEM, and R
  • Previous experience in antibody-drug conjugates and/or oligonucleotides is desirable
  • Ability to innovate dosing strategies in a data-driven manner for this novel class of molecule
  • Strong interpersonal and relationship building skills with demonstrated experience to lead and influence within a matrixed environment.
  • Ability to work and communicate in an open and clear manner, listening effectively and inviting responses and discussions with internal and external partners
  • Must be independent and highly motivated, with the ability to multi-task, driving strategy and execution, in a fast-paced collaborative 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.

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