Principal Scientist, DMPK

The Principal Scientist, DMPK is responsible for planning and performing in vitro and in vivo ADME studies that support research and development activities. The role also includes communicating experimental results to leadership and project teams.

This position works cross-functionally with internal departments and external partners as part of discovery science project teams, while supporting adherence to regulatory requirements and internal Standard Operating Procedures (SOPs).

This is a global commercial biopharmaceutical organization. For over 25 years, the team has been deeply committed to a unified purpose: extending life's moments for children and adults living with rare diseases.

The organization fosters an inclusive culture where everyone feels valued, respected, and empowered. Candidates from all backgrounds are encouraged to apply, supporting a strong sense of belonging.

Visit the company website to learn more about its mission and culture.

• Under limited direction, plans, initiates, and executes DMPK studies; interprets and communicates results within a multidisciplinary team.
• Collaborates with research and development teams to plan, schedule, and conduct DMPK studies aligned with candidate nomination and IND/NDA timelines.
• Serves as the DMPK representative on project teams; presents and interprets data for cross-functional stakeholders (internal and external).
• Performs hands‑on in vitro and in vivo DMPK studies, including but not limited to:
• Metabolic stability
• Metabolite profiling/identification
• CYP inhibition and induction studies
• Pharmacokinetic studies
• Radio labeled studies in animals and humans
• Documents experimental details and prepares reports; contributes to DMPK documentation for candidate nomination and IND/NDA submissions.
• Ensures scientific quality and integrity of experimental data.
• Oversees and/or leads interactions with external Contract Research Organizations (CROs).
• Complies with all safety and regulatory guidelines.
• Supports general laboratory operations, including:
• Equipment maintenance
• Troubleshooting
• Performs additional tasks as assigned by management.

• PhD in Chemistry, Biology, Pharmaceutical Sciences, Pharmacology, or a related discipline with 5+ years of drug metabolism experience

OR

• Master's degree in a related discipline with 6+ years of drug metabolism experience

• Hands‑on experience conducting in vitro and in vivo DMPK studies.
• Strong background in drug metabolism, biotransformation, pharmacokinetics, pharmacodynamics, and bioanalytical principles.
• Experience operating LC‑MS/MS instrumentation.
• Proven ability to develop study protocols and author reports supporting candidate nomination and IND/NDA submissions.
• Ability to solve complex scientific problems and generate high‑quality data across multiple projects.
• Strong collaboration skills in a multidisciplinary team environment.
• Proficiency with Microsoft Office.
• Excellent written and verbal communication skills.
• Ability to balance independent work with collaboration in a fast‑paced, matrixed environment.
• Strong analytical, problem‑solving, planning, and organizational skills with the ability to manage multiple priorities.

• PhD (if not already required by experience pathway)
• Experience with radio labeled studies
• Hands‑on experience troubleshooting LC‑MS systems and automated liquid handlers
• Prior experience supporting IND and/or NDA submissions
• Experience with cell‑based assays (e.g., hepatocytes, transporter systems)
• Proficiency in Win Nonlin or similar pharmacokinetic software