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Senior Medical Director – Clinical Development, Prostate Cancer
Bristol Myers SquibbSenior Medical Director executing clinical development plans for prostate cancer at RayzeBio. Leading cross-functional study teams and mentoring clinical scientists in a collaborative environment.
About the role
Key responsibilities & impact- 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 and build and manage 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.
Requirements
What you’ll need- MD 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 required.
Benefits
Comp & perks- Health Coverage: Medical, pharmacy, dental, and vision care.
- Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
- Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
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Hard Skills & Tools
Clinical Study DesignProtocol WritingData ReviewInvestigator MeetingsStrategic PlanningContingency PlanningTechnical AdviceCompliance with Ethical GuidelinesClinical Trial ExecutionAI Utilization in Drug Development
Soft Skills
Relationship ManagementMentoringCollaborationCommunication
Certifications
MD or Equivalent