What are the responsibilities and job description for the Director, Clinical Pharmacology and Pharmacometrics position at Dyne Tx?
Our commitment to people with muscle diseases is our greatest strength.
Director, Clinical Pharmacology and Pharmacometrics
Department : 125 Translational Biomarkers
Location : Waltham, MA
Company Overview :
Dyne Therapeutics is a clinical-stage muscle disease company focused on 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. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit Dyne Therapeutics
Role Summary :
The Director, Clinical Pharmacology and Pharmacometrics is responsible for providing strategies, plans, and deliverables on pharmacology and related pharmacometrics & quantitative analytics for the advancement of select programs across all stages of drug development at Dyne Therapeutics. Primary responsibilities include the strategic planning and execution of translational & clinical pharmacology activities, as a core member of program teams, in seamless coordination and collaboration with other internal functions and subject matter experts (SMEs).
The person in this role has a strong knowledge of best practices in Clinical Pharmacology and Pharmacometrics, hands-on experience in designing and executing clinical pharmacology studies and PK / PD modeling plans, and the ability to make data-driven decisions and contributions towards clinical development strategies, clinical trial design strategies, and dosing decisions, based on preclinical, clinical, and natural history information. This role works seamlessly with colleagues in the Translational Biomarkers & Pharmacology department and, as a core member of high-paced program teams, with SMEs in platform discovery, preclinical research, clinical development, clinical operations, regulatory, CMC, and program management, enabling 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 :
- Provide strategies and plans for integrative clinical pharmacology, quantitative data analytics including PK / PD modeling, and translational biomarkers, in alignment with Regulatory requirements as well as corporate and R&D goals, thereby enabling the advancement of Dyne programs across all stages of drug development.
- Represent the Translational Biomarkers & Pharmacology department as SME, providing expertise and guidance on pharmacology and quantitative PK / PD to R&D program teams and in close collaboration with Medical, Biometrics, Pharmacovigilance, Preclinical Tox, and ADME / DMPK SMEs.
- Identify and manage consultants and vendors to support clinical pharmacology and related activities.
- Author high-quality regulatory documents.
- Accountable for adherence to agreed timelines and budgets to ensure execution of deliverables from Clinical Pharmacology studies and drug development programs.
- Collaborate cross-functionally with all relevant areas to support corporate objectives.
Education and Skills Requirements :
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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