Senior Director – Clinical Pharmacology
| Company | Bristol Myers Squibb |
|---|---|
| Location | San Diego, CA, USA, Lawrence Township, NJ, USA |
| Salary | $241000 – $316000 |
| Type | Full-Time |
| Degrees | PharmD, PhD, MD |
| Experience Level | Senior, Expert or higher |
Requirements
- PhD, MD or PharmD with at least 8-10 years of pharmaceutical or biotech experience in clinical pharmacology and oncology drug development
- Experience with early and late-stage clinical development, IND and filing dossier
- Strong background and expertise in Clinical Pharmacology, PK and PK/PD demonstrated by major Regulatory submission experience and/or scientific publications
- Skilled in clinical research and understand the process of pharmaceutical product development and approval
- Able to function in a highly regulated environment and to adhere to all RayzeBio guidelines and standard operating procedures (SOP’s)
- Solid understanding of GCP and ICH guidelines
Responsibilities
- Develop clinical pharmacology strategy and related clinical development plan consistent with the development strategy, program goals, and the US/international regulatory guidance for radiopharmaceuticals
- Collaborate with DMPK, clinical development, and CMC teams to define clinical pharmacology data needed to support NDA and drug label
- Determine scope, design, plan, analyze and interpret pharmacokinetic and pharmacodynamics (PK/PD) in company-sponsored studies, including development of appropriate population PK models, and PK/PD analysis required from a development and regulatory perspective to take a project from concept stage to commercialization
- Provide clinical pharmacology expertise to the project team and closely collaborate with Clinical Operations, Clinical Development, Biometrics, and Regulatory Affairs
- Contribute to the design and execution of Phase 1 clinical pharmacology (eg, drug-drug interactions, relative bioavailability/bioequivalence, special populations, and thorough QT, etc.) and dosimetry studies
- Contribute to writing of protocols, investigator brochures, clinical study reports, and review of other clinical trial documents
- Plan, prepare, and review clinical pharmacology section of the regulatory documents (IND, IMPD, IB, NDA CTD, etc.), participate in drafting publications and making scientific presentations consistent with development strategies
- Serve as the primary Clinical Pharmacology Lead and effectively participate in cross functional teams to ensure integration of clinical pharmacology principles into project plans and study design
- Represent clinical pharmacology at regulatory meetings and advisory hearings with global health authorities
Preferred Qualifications
- Radiopharmaceutical experience is preferred but not required