Job Description Summary
The Principle Scientist, DMPK is responsible for planning and performing in vitro and in vivo ADME studies that support PTCβs research and development activities. Communicates experimental results to supervisor and the project team. Works cross-functionally with internal departments and external resources as appropriate, and supports adherence to regulatory requirements and company SOPs.
Responsibilities
- Under limited direction, plans, initiates, executes DMPK studies, and interprets/communicates results as part of a multi-disciplinary team.
- Plans, schedules, and conducts DMPK studies aligned to development candidate nomination and IND/NDA timeline requirements.
- Serves as DMPK representative on project teams; interprets and presents data/results to cross-functional internal/external teams.
- Performs hands-on in vitro/in vivo DMPK studies including metabolic stability/metabolite profiling, CYP inhibition/induction, pharmacokinetics, and radiolabeled studies in lab animals and humans.
- Documents work in lab notebooks, writes reports, and prepares DMPK documents for development candidate nomination and IND/NDA purposes.
- Ensures scientific quality of experimental data.
- Provides direct oversight and/or leads interactions with external CROs.
- Follows safety and regulatory guidelines.
Qualifications
- PhD in Chemistry, Biology, Pharmaceutical science, Pharmacology (or related) with 5+ years drug metabolism experience, OR Masterβs degree with 6+ years drug metabolism experience.
Skills/Abilities Required
- Hands-on in vitro/in vivo DMPK, drug metabolism/biotransformation, pharmacokinetics/pharmacodynamics/bioanalytical principles.
- Hands-on LC-MS/MS use; ability to develop protocols and write study reports.
- Strong problem-solving, independent and team collaboration in a fast-paced matrix environment; analytical, planning/organization, and communication skills; Microsoft Office.
Base Salary Range: $153,500β$185,000 (contingent on education, background, experience, and internal equity). Eligible for short- and long-term incentives and medical/dental/vision/retirement savings plans.