Senior Director, Clinical Pharmacology

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RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

The Senior Director – Clinical Pharmacology will be a key member of the development team, developing clinical pharmacology strategy, leading the design, execution, interpretation and reporting of clinical pharmacology data, and serve as clinical pharmacology lead on studies and project teams.  The role will support projects at various stages of development, playing an active role in our drug discovery and development efforts to advance RayzeBio’s radiopharmaceutical pipeline.

Job Responsibilities:

Essential duties and responsibilities include the following.  Other duties may be assigned.

• 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.

• Other duties as assigned.

• Willing to travel up to approximately 10% of the time (if not based in San Diego area). 

Education and Experience:

• PhD, MD or PharmD with at least 8-10 years of pharmaceutical or biotech experience (10+ years for Exec. Director) in clinical pharmacology and oncology drug development. Radiopharmaceutical experience is preferred but not required.

Skills and Qualifications:

• Patient-focused, with deep commitment to understanding needs and improving the lives of patients with cancers and a passion for developing novel therapeutics

• Motivated to work in a fast-paced, high accountability, small company environment. A "can do" and collegial professional who leads through influence and interpersonal skills.

• Demonstrate