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 Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a 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 at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
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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The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.
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.
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.
Dyne Therapeutics Waltham, Massachusetts, USA Office
1560 Trapelo Rd, Waltham, MA, United States, 02451
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