Principal Scientist, ADME-PK

Dyne Therapeutics • Waltham, MA

9d • Onsite

About The Position

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 Principal S cientist , ADME-PK in Preclinical Development (PCD) department utilize s their knowledge in drug metabolism, ADME concepts, pharmacokinetics, pharmacodynamic and bioanalytical principles to advance Dyne ’s efforts surrounding delivery of therapeutic payloads to muscle and CNS tissues with the FORCE platform . This role is based in Waltham, MA.

Requirements

• PhD in Pharmacokinetics, Pharmacology, Pharmaceutics, Biomedical Sciences or other relevant field with >6 years (MS with >8 years, BS with >12 years) of experience in the biopharmaceutical industry, with evidence of drug development experience
• Strong knowledge of drug metabolism, ADME concepts, pharmacokinetics, pharmacodynamics and bioanalytical principles
• Excellent communication (verbal and written) and presentation skills, as well as interpersonal skills and the ability to represent PCD in a team environment

Nice To Haves

• F amiliarity with regulatory submission including FIH dosing strategy is highly desirable
• Proficient in using WinNonlin or other pharmacokinetic software
• Experience with PK characterization of protein therapeutics or antibody-drug conjugates (ADCs) is desired

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
• 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
• Facilitate strategic scientific communication via meetings, abstracts and manuscripts

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees