Medical Director, Radiopharmaceutical Imaging (RPI)

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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 Medical Director RPI has responsibility for the development of RayzeBio’s diagnostic imaging pipeline across disease areas, including but not limited to prostate cancer, hepatocellular cancer and neuroendocrine tumors. Responsibilities may include support for IND preparation, regulatory authority interactions, design, and execution of Phase 0 to Phase 3 clinical trials, and medical monitoring. This role provides medical direction and high quality scientific and clinical knowledge to guide the strategy and execution of RayzeBio’s diagnostic imaging portfolio. This role works collaboratively with multi-disciplinary teams responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted within RayzeBio’s portfolio to ensure the program meets the needs of patients and RayzeBio’s business.

Job Responsibilities

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

• Interact with clinical investigators and thought leaders to design a diagnostic imaging strategic plan for nominated candidates

• Lead internal project teams, and partner with investigators and CROs to design and implement clinical studies of radiopharmaceutical imaging agents.

• Contribute to writing of protocols, investigator brochures, clinical study reports, and review of other clinical trial and regulatory documents

• Conduct investigator meetings and lead site qualification and initiation visits with clinical trial investigators

• Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets

• Translate findings from research and nonclinical studies into diagnostic imaging development opportunities

• Oversee Data Review and Independent Data Monitoring Committees as applicable

• Conduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines

• Establish and maintain positive relationships with clinical trial investigators and thought leaders

• Serve as clinical lead for regulatory interactions, including preparation of briefing documents and attendance and presentation at health authority meetings.

• Work closely with commercial and medical affairs organization to develop and execute on a diagnostic imaging program for RayzeBio portfolio in radiopharmaceutical imaging.

• Willing to travel approximately 30% of the time. Evening and weekend work will be involved.

Education and Experience

• MD or equivalent with at least 5 years of pharmaceutical, biotech experience or academic clinical experience in oncology diagnostic development or 3 years’ experience for candidates with track record of developing radiopharmaceutical imaging agents through a regulatory process.

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, and small company environment. A "can do" and collegial professional who leads through influence and i