Senior Director, Clinical Development - Prostate Cancer

Life at BMS

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/

RayzeBio has assets in development in the prostate cancer space, and the Clinical Development lead will be responsible for helping develop and execute the strategy for these assets. They will be responsible for the clinical development plans for these assets across the full range of development lifecycle i.e from IND to Phase3 registrational studies. They will grow and manage the clinical team in prostate cancer as needed to lead additional programs. This role will work closely with research and translational medicine teams to help inform on clinical stage assets as well as for pipeline molecules, they will actively participate in BD efforts and due diligence efforts to grow Rayze Bio’s portfolio. This role will engage with BMS oncology leaders to develop combination strategies as appropriate across the BMS and Rayze Bio portfolios and support the prostate disease area strategies.

This role provides clinical direction and high-quality scientific and clinical knowledge to lead the strategy and execution of RayzeBio’s clinical development plans for molecules in early and late development. Responsibilities include support for IND preparation, regulatory authority interactions, design and execution of Phase 1 to Phase 3 clinical trials, and medical monitoring. This role will lead cross-functional study 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.

Responsibilities:

• Interact with clinical investigators and thought leaders to design a clinical development plan for nominated drug candidates
• Lead internal study teams, and partner with investigators and CROs to design and implement clinical studies
• Work closely with GPLs to ensure development and commercial optimization of Rayze Bio assets
• 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 clinical development opportunities
• Oversee Data Review and Independent Data Monitoring Committees
• 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
• As needed, serve as clinical lead for regulatory interactions, including preparation of briefing documents and attendance and presentation at health authority meetings. Oversee regulatory submissions for assets in prostate cancer indications
• Lead cross-functional study teams and supervise and mentor clinical scientists and medical directors in executing the programs for prostate cancers.
• Recruit, build, and manage a team of medical directors and clinical scientists as needed based on programmatic needs
• Leverages AI to drive program, portfolio, or functional performance through prioritization and scaled adoption
• Willing to travel approximately 30% of the time.

Education and Experience

• MD, PhD. PharmD or equivalent ideally with sub-specialty training in oncology and at least 10 years of pharmaceutical/biotech/academic experience in oncology solid tumor clinical development is required (radiopharmaceutical experience is preferred but not required).
• Drug development experience in prostate cancer is preferred but not required.
• Experience in NDA/MAA preparation and submission and in complex health authority interactions globally.
• Experience in all aspects of protocol conduct, both early and late phase, including protocol writing, start-up, study execution, analysis and reporting.
• Experience working closely with investigative sites, including principal investigators, sub-investigators, study coordinators and other site personnel involved in clinical trials.

Skills and Qualifications

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