Director, Pharmacokinetics
Merck
9 hours ago
On-site
West Point, PA
Clinical Research and Development
Biotransformation (MetID) Lead (Director) — Head the Biotransformation (MetID) group within Drug Metabolism & Pharmacokinetics (DMPK).
Key Responsibilities:
- Provide strategic/technical leadership for biotransformation/metabolite identification from early discovery through late-stage development; ensure comprehensive metabolite profiling and risk understanding.
- Oversee in vitro/in vivo MetID studies in relevant matrices (plasma, urine, bile, etc.); use high-resolution LC-MS/MS and other mass spectrometry techniques for structural elucidation.
- Integrate metabolite findings into program decisions; ensure strategies meet regulatory expectations and identify human-specific/disproportionate metabolites.
- Anticipate metabolism-related liabilities (e.g., reactive/genotoxic metabolites, species differences) and propose risk-mitigation.
- Collaborate with medicinal chemistry, toxicology, pharmacology, and bioanalysis to interpret data for safety/pharmacology and guide derisking and study design.
- Lead/mentor MetID scientists; manage priorities/resources; approve reports/presentations; contribute to IND/NDA sections on metabolite ID and safety.
Qualifications (Required):
- Ph.D. (Organic/Analytical Chemistry, Pharmacology, Pharmaceutical Sciences or related) with 8+ years industry drug metabolism experience, or MS with >12 years.
- Deep expertise in metabolite identification/biotransformation; hands-on structural assignment (purification, LC-MS/MS, high-resolution MS) and strong publication record.
- Broad ADME/drug metabolism knowledge across discovery and development; in vitro (e.g., hepatocytes, enzyme phenotyping) and in vivo/human mass balance; familiarity with ICH M3(R2) and FDA MIST.
- Proven scientific leadership; experience supervising/mentoring; strong communication and project management.
Preferred:
- NDA/regulatory filing experience.
- Emerging MetID technologies (automation, fragmentation, bioinformatics).
- Small molecules required; peptide/protein therapeutics strongly desired.
Benefits (explicit): Medical/dental/vision, insurance, retirement (401(k)), paid holidays, vacation, compassionate/sick days.
Apply: https://jobs.merck.com/us/en (Workday Jobs Hub for current employees). Application deadline listed on posting.
Key Responsibilities:
- Provide strategic/technical leadership for biotransformation/metabolite identification from early discovery through late-stage development; ensure comprehensive metabolite profiling and risk understanding.
- Oversee in vitro/in vivo MetID studies in relevant matrices (plasma, urine, bile, etc.); use high-resolution LC-MS/MS and other mass spectrometry techniques for structural elucidation.
- Integrate metabolite findings into program decisions; ensure strategies meet regulatory expectations and identify human-specific/disproportionate metabolites.
- Anticipate metabolism-related liabilities (e.g., reactive/genotoxic metabolites, species differences) and propose risk-mitigation.
- Collaborate with medicinal chemistry, toxicology, pharmacology, and bioanalysis to interpret data for safety/pharmacology and guide derisking and study design.
- Lead/mentor MetID scientists; manage priorities/resources; approve reports/presentations; contribute to IND/NDA sections on metabolite ID and safety.
Qualifications (Required):
- Ph.D. (Organic/Analytical Chemistry, Pharmacology, Pharmaceutical Sciences or related) with 8+ years industry drug metabolism experience, or MS with >12 years.
- Deep expertise in metabolite identification/biotransformation; hands-on structural assignment (purification, LC-MS/MS, high-resolution MS) and strong publication record.
- Broad ADME/drug metabolism knowledge across discovery and development; in vitro (e.g., hepatocytes, enzyme phenotyping) and in vivo/human mass balance; familiarity with ICH M3(R2) and FDA MIST.
- Proven scientific leadership; experience supervising/mentoring; strong communication and project management.
Preferred:
- NDA/regulatory filing experience.
- Emerging MetID technologies (automation, fragmentation, bioinformatics).
- Small molecules required; peptide/protein therapeutics strongly desired.
Benefits (explicit): Medical/dental/vision, insurance, retirement (401(k)), paid holidays, vacation, compassionate/sick days.
Apply: https://jobs.merck.com/us/en (Workday Jobs Hub for current employees). Application deadline listed on posting.