Director, Clinical Pharmacology

1 Days Old

Job Details
Company Overview: 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 Director of Clinical Pharmacology will lead 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 will bring 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.
Primary Responsibilities Develop and implement clinical pharmacology and quantitative modeling strategies aligned with regulatory requirements and Dyne's R&D objectives. Serve as the subject matter expert for Clinical Pharmacology & Biomarkers, providing 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. Author 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. Education and Experience Requirements PhD, PharmD, or equivalent in Pharmacology, Pharmaceutical Sciences, Engineering, Physics, Applied Mathematics, or Computational Sciences. Minimum of 10 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.
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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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Location:
Waltham, MA, United States
Category:
Management Occupations

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