We have a current opportunity for a Director of Clinical Pharmacology on a permanent basis. The position is fully remote.
Key Responsibilities:
- Lead the design, execution, and analysis of clinical pharmacology studies, including first-in-human (FIH), pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug interaction (DDI) studies.
- Develop clinical pharmacology plans that support regulatory submissions (IND, NDA, BLA) and provide strategic input throughout all stages of drug development.
- Collaborate with clinical, regulatory, biostatistics, and other R&D teams to interpret data and guide decision-making in clinical development.
- Serve as the clinical pharmacology expert in interactions with regulatory authorities, presenting clinical pharmacology data and strategies.
- Support dose selection strategies, contribute to clinical trial design, and ensure optimal use of modeling and simulation approaches.
- Mentor and manage a growing team of clinical pharmacologists and pharmacometricians.
- Stay current on new scientific developments, regulatory guidelines, and industry trends in clinical pharmacology and related fields.
Qualifications:
- PhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, or a related discipline.
- 8+ years of experience in clinical pharmacology and drug development within the pharmaceutical or biotech industry.
- Proven track record of successfully leading clinical pharmacology programs from early to late-stage development.
- Must have large molcule and strong experience with MAB.
