Senior Director, Clinical Development - Prostate Cancer

Bristol Myers Squibb

4d • $241,768 - $292,966 • Remote

About The Position

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, is seeking a clinical development lead for its prostate cancer assets. The role will help develop and execute strategy and clinical development plans across the full lifecycle, from IND through Phase 3 registrational studies. The lead will work with research and translational medicine teams to inform development of clinical-stage assets and pipeline molecules, contribute to business development and due diligence, and partner with BMS oncology leaders on combination strategies and prostate disease-area strategy. The position may also grow and manage a prostate cancer clinical team as program needs require.

The role provides clinical direction and scientific expertise for early- and late-stage programs, including IND preparation, regulatory interactions, Phase 1 through Phase 3 trial design and execution, and medical monitoring. It leads cross-functional study teams through study design, implementation, monitoring, analysis, and reporting, ensuring programs address patient needs and business objectives. The position is remote in the United States and involves approximately 30% travel.

Requirements

• MD, PhD, PharmD, or equivalent; oncology subspecialty training is ideal.
• At least 10 years of pharmaceutical, biotech, or academic experience in oncology solid tumor clinical development.
• Experience preparing and submitting NDAs/MAAs and managing complex global health authority interactions.
• Experience across protocol conduct in early- and late-phase development, including protocol writing, study start-up, execution, analysis, and reporting.
• Experience working closely with investigative sites, including principal investigators, sub-investigators, study coordinators, and other clinical trial personnel.
• Patient-focused, with a deep commitment to understanding patient needs and improving the lives of people with cancer, and a passion for developing novel therapeutics.
• Ability and motivation to work in a fast-paced, high-accountability, small-company environment; collegial, proactive, and able to lead through influence and interpersonal skills.
• Demonstrated ability to deliver results under compressed timelines, prioritize work, meet deadlines, and maintain high standards and attention to detail.
• Ability to collaborate successfully across functions and lead clinical and cross-functional teams in a biotech environment.
• Ability to manage multiple stakeholder engagements across development and commercial organizations.
• Intellectual curiosity, courage to challenge existing approaches, and interest in improving work.
• Strong written, oral, and presentation skills.
• Strong critical, strategic, and analytical thinking skills.
• Knowledge of clinical research and the pharmaceutical product development and approval process.
• Ability to work in a highly regulated environment and comply with RayzeBio guidelines and standard operating procedures.
• Solid understanding of GCP and ICH guidelines.

Nice To Haves

• Radiopharmaceutical experience.
• Drug development experience in prostate cancer.

Responsibilities

• Interact with clinical investigators and thought leaders to design clinical development plans for nominated drug candidates.
• Lead internal study teams and partner with investigators and CROs to design and implement clinical studies.
• Work with GPLs to support development and commercial optimization of RayzeBio assets.
• Contribute to 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.
• Execute drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets.
• Translate research and nonclinical findings into clinical development opportunities.
• Oversee Data Review and Independent Data Monitoring Committees.
• Conduct clinical trials according to applicable pharmaceutical industry ethical guidelines and ensure compliance with those guidelines.
• Establish and maintain positive relationships with clinical trial investigators and thought leaders.
• As needed, lead regulatory interactions, including preparing briefing documents and attending and presenting at health authority meetings; oversee regulatory submissions for prostate cancer indications.
• Lead cross-functional study teams and supervise and mentor clinical scientists and medical directors working on prostate cancer programs.
• Recruit, build, and manage a team of medical directors and clinical scientists as program needs require.
• Leverage AI to improve program, portfolio, or functional performance through prioritization and scaled adoption.
• Travel approximately 30% of the time.

Benefits

• Potential eligibility for comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance.
• U.S.-based exempt employees are eligible for Flexible Time Off without a set accrual limit, subject to manager approval, and 11 paid company holidays per year.
• Non-exempt employees, RayzeBio employees, and employees 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, additional time-off benefits may include paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leave for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees receive an annual Global Shutdown between Christmas Day and New Year's Day.
• May be eligible for discretionary incentive cash and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree