Dyne Therapeutics · 6 hours ago
Director, Clinical Pharmacology
Waltham, MA
Full-time
Onsite
Director/Executive
$190K/yr - $233K/yr
10+ years expDyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. The Director of Clinical Pharmacology will lead the strategic planning and execution of clinical pharmacology activities to support drug development programs, including designing pharmacology strategies and collaborating with internal teams and external partners.
BiotechnologyHealth CareMedicalPharmaceutical
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
Qualification
Required
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
Company
Dyne Therapeutics
Dyne Therapeutics is a developer of targeted therapies intended for serious muscle diseases.
51-200 employees
H1B Sponsorship
Dyne Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (7)
2023 (1)
2022 (3)
2021 (6)
Funding
Current Stage
Public CompanyTotal Funding
$1.67BKey Investors
Hercules CapitalAtlas Venture
2025-12-09Post Ipo Equity· $402.5M
2025-06-30Post Ipo Equity· $230M
2025-06-30Post Ipo Debt· $100M
Leadership Team
John Cox
Chief Executive Officer
Recent News
2025-12-24
MarketScreener
2025-12-24
2025-12-24
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