Associate Director, Clinical Pharmacology

Dyne Therapeutics • Waltham, MA

3d • Onsite

About The Position

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook. Role Summary The Associate Director, Clinical Pharmacology supports the strategic planning and execution of clinical pharmacology and pharmacometrics activities to support Dyne Therapeutics’ drug development programs across all stages. This role is responsible for designing and implementing pharmacology and PK/PD modeling & simulation strategies, contributing to translational and early & late clinical development, and collaborating cross-functionally with internal teams and external partners. The ideal candidate brings deep expertise in clinical pharmacology, hands-on experience with PK/PD modeling (including population PK/PD, PBPK, and QSP), and the ability to translate data into actionable insights for clinical trial design and regulatory submissions.

Requirements

• PhD, PharmD, or equivalent in Pharmacology, Pharmaceutical Sciences, Engineering, Physics, Applied Mathematics, or Computational Sciences.
• Minimum of 8 years of experience in clinical pharmacology or biomarker-related functions within the biopharmaceutical industry.
• Strong knowledge of PK/PD modeling and simulation, regulatory guidance, and drug development processes—particularly for oligonucleotides, biologics, and rare diseases.
• Experience preparing regulatory documents including pre-IND, IND, IB, CTA, and BLA submissions.
• Proficiency in modeling tools such as R, Monolix (or equivalent), and data mining platforms.
• Proven ability to develop innovative dosing strategies for novel drug modalities.
• Excellent interpersonal and leadership skills with experience influencing in a matrixed environment.
• Strong communication skills with the ability to foster collaboration and open dialogue across teams.
• Self-motivated and adaptable, with the ability to manage multiple priorities in a fast-paced setting.

Responsibilities

• Develop and implement clinical pharmacology and quantitative modeling strategies aligned with regulatory requirements and Dyne’s R&D objectives
• Provide guidance to cross-functional teams including Medical, Biometrics, Pharmacovigilance, Preclinical Toxicology, ADME/DMPK, and Clinical Development
• Conduct hands-on PK/PD modeling and data analyses to support progression from preclinical through late-stage clinical development
• Manage external consultants and vendors supporting clinical pharmacology activities.
• Support the authoring of high-quality regulatory documents, including INDs, IBs, briefing packages, study reports, and BLAs
• Ensure timely and budget-conscious execution of clinical pharmacology deliverables.
• Collaborate across departments to support program advancement and corporate goals

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees