Senior Principal Scientist, ADME-PK

Role Summary:

The Senior Principal Scientist, ADME/PK leads preclinical PK and ADME strategy for Dyne’s drug candidates, serving as the ADME‑PK subject matter expert on discovery and program teams. This role designs and executes internal and external studies, develops translational PK and modeling approaches to support clinical dose projections, and partners cross‑functionally to advance programs from discovery through clinical development. The position authors regulatory submissions, defines science‑based ADME strategies aligned with regulatory expectations, and communicates findings through high‑quality written and verbal scientific outputs.

This role is based in Waltham, MA and does not offer a remote option. 

Primary Responsibilities:

• Design and execute internal/external preclinical studies to understand the pharmacokinetics (PK) and absorption, metabolism, distribution, and excretion (ADME) of Dyne’s drug candidates.
• Represent PCD as the ADME-PK subject matter expert on discovery and program teams.
• Partner with and support Research, Toxicology, Translational Biomarkers, Clinical, Regulatory, Project Management and other Dyne departments.
• Collaborate with Clinical Pharmacology/Pharmacometrics to develop quantitative tools to translate PK/PD relationship from preclinical to clinical.
• Develop PK/PD, QSP, PBPK, or other appropriate models to capture preclinical data, enable clinical scaling and first in human dose projection.
• Author high quality Regulatory documents including INDs, CTAs, and NDA/BLA filings.
• Prepare strategic and science-based ADME strategies that meet regulatory requirements and program goals.
• Identify relevant ADME/PK endpoints for incorporating into early-stage compound design and prioritization.
• Facilitate strategic scientific communication via meetings, abstracts and manuscripts.

Education and Skills Requirements:

• PhD or equivalent experience in a scientific discipline and minimum of 12+ years related experience.
• Strong knowledge of drug metabolism, ADME concepts, pharmacokinetics, pharmacodynamics and bioanalytical principles.
• Familiarity with regulatory submission including FIH dosing strategy is highly desirable.
• Proficient in using WinNonlin or other pharmacokinetic software for non-compartmental analysis.
• PK/PD modeling experience.
• Excellent communication (verbal and written) and presentation skills, as well as interpersonal skills and the ability to represent PCD in a team environment.
• Experience with PK characterization of protein therapeutics or antibody-drug conjugates (ADCs) is desired.
• Understanding PK and modeling requirements for subcutaneous administration of biologics is desired.

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