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

• 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.
• Demonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering deadlines with high-performance standards and attention to detail.
• Demonstrated ability to collaborate successfully with multiple functions in a team environment
• Demonstrated leadership of clinical and cross-functional teams in a biotech environment
• Demonstrated ability to manage multiple stakeholder engagements across development and commercial organizations
• Intellectually curious with courage to challenge and seek new ways to improve work.
• Strong written and oral communication skills, including presentation skills.
• Strong critical, strategic, and analytical thinking skills.
• 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.

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Remote - United States - US: $241,768 - $292,966

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

RayzeBio and Bristol Myers Squibb

RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.

Supporting People with Disabilities

BMS and RayzeBio are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS and RayzeBio will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only:  If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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R1608079 : Senior Director, Clinical Development - Prostate Cancer