Principal Scientist, ADME-PK
Dyne Therapeutics
June 29, 2026
On-site
Waltham, MA
Clinical Research and Development
Role Summary:
Principal Scientist, ADME/PK leads preclinical PK and ADME strategy for drug candidates as the ADME-PK subject matter expert. Designs and executes internal/external studies, develops translational PK and modeling for clinical dose projections, partners cross-functionally from discovery through clinical development, authors regulatory submissions, and communicates findings.
Location: Waltham, MA (no remote option).
Primary Responsibilities:
- Design and execute internal/external preclinical ADME/PK studies to characterize absorption, metabolism, distribution, and excretion.
- Serve as ADME-PK SME on discovery and program teams.
- Partner with Research, Toxicology, Translational Biomarkers, Clinical, Regulatory, Project Management, and others.
- Collaborate with Clinical Pharmacology/Pharmacometrics to translate PK/PD from preclinical to clinical.
- Develop PK/PD, QSP, PBPK, or other models for clinical scaling and first-in-human dose projection.
- Author regulatory documents (INDs, CTAs, NDA/BLA filings).
- Prepare science-based ADME strategies meeting regulatory and program goals.
- Identify ADME/PK endpoints for early compound design and prioritization.
- Communicate via meetings, abstracts, and manuscripts.
Education and Skills Requirements:
- PhD (or equivalent) and 8+ years related experience.
- Strong ADME/drug metabolism, PK/PD, and bioanalytical knowledge.
- WinNonlin (or similar) for non-compartmental analysis.
- PK/PD modeling experience.
- Excellent written/verbal communication and presentation skills.
- Regulatory submission familiarity, including FIH dosing strategy (highly desirable).
- Protein therapeutics or ADC PK characterization experience (desired).
- PK/modeling for subcutaneous biologic administration (desired).
Principal Scientist, ADME/PK leads preclinical PK and ADME strategy for drug candidates as the ADME-PK subject matter expert. Designs and executes internal/external studies, develops translational PK and modeling for clinical dose projections, partners cross-functionally from discovery through clinical development, authors regulatory submissions, and communicates findings.
Location: Waltham, MA (no remote option).
Primary Responsibilities:
- Design and execute internal/external preclinical ADME/PK studies to characterize absorption, metabolism, distribution, and excretion.
- Serve as ADME-PK SME on discovery and program teams.
- Partner with Research, Toxicology, Translational Biomarkers, Clinical, Regulatory, Project Management, and others.
- Collaborate with Clinical Pharmacology/Pharmacometrics to translate PK/PD from preclinical to clinical.
- Develop PK/PD, QSP, PBPK, or other models for clinical scaling and first-in-human dose projection.
- Author regulatory documents (INDs, CTAs, NDA/BLA filings).
- Prepare science-based ADME strategies meeting regulatory and program goals.
- Identify ADME/PK endpoints for early compound design and prioritization.
- Communicate via meetings, abstracts, and manuscripts.
Education and Skills Requirements:
- PhD (or equivalent) and 8+ years related experience.
- Strong ADME/drug metabolism, PK/PD, and bioanalytical knowledge.
- WinNonlin (or similar) for non-compartmental analysis.
- PK/PD modeling experience.
- Excellent written/verbal communication and presentation skills.
- Regulatory submission familiarity, including FIH dosing strategy (highly desirable).
- Protein therapeutics or ADC PK characterization experience (desired).
- PK/modeling for subcutaneous biologic administration (desired).