Senior Medical Director, Clinical Development – Radiopharmaceuticals, HCC and GI Cancers
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Job Description
Medical Director leading HCC and GI oncology clinical development for RayzeBio, a BMS subsidiary. Overseeing radiopharmaceutical trials from IND through Phase 3 and regulatory submission.
Responsibilities:
- Oversee clinical development plans for hepatocellular carcinoma assets across the development lifecycle, from IND through Phase 3 registrational studies
- Engage BMS oncology leaders to develop combination strategies across BMS and RayzeBio portfolios
- Support HCC and GI disease-area strategies
- Support IND preparation and regulatory authority interactions
- Design and execute Phase 1 to Phase 3 clinical trials
- Provide medical monitoring
- Lead cross-functional study teams responsible for study design, implementation, monitoring, analysis, and reporting
- Interact with clinical investigators and thought leaders to design clinical development plans
- Partner with investigators and CROs to design and implement clinical studies
- Work with asset GPLs on development and commercial optimization
- Contribute to protocols, investigator brochures, clinical study reports, and other clinical trial and regulatory documents
- Conduct investigator meetings and lead site qualification and initiation visits
- Execute drug-development strategic plans and develop contingency plans
- Translate research and nonclinical findings into clinical development opportunities
- Oversee Data Review and Independent Data Monitoring Committees
- Ensure clinical trials follow pharmaceutical-industry ethical guidelines and external compliance requirements
- Maintain relationships with clinical investigators and thought leaders
- Lead regulatory interactions, including briefing documents and health-authority meetings
- Collaborate across development and commercial teams
- Leverage AI to improve program, portfolio, or functional performance
- Supervise and mentor clinical scientists and junior MDs
Requirements:
- MD with sub-specialty training in oncology required
- 5+ years of pharmaceutical/biotech experience in oncology solid-tumor clinical development required
- Expertise in HCC and/or GI cancers required
- Radiopharmaceutical experience preferred but not required
- Patient-focused commitment to improving outcomes for patients with cancer
- Ability to work in a fast-paced, high-accountability, small-company environment
- Demonstrated record of accomplishment in a compressed time frame
- Ability to prioritize tasks and deliver on deadlines with high-performance standards and attention to detail
- Demonstrated ability to collaborate across multiple functions
- Strong written, oral, and presentation skills
- Strong critical, strategic, and analytical thinking skills
- Experience with protocol writing, study start-up, study execution, analysis, and reporting
- Experience working with investigative sites, principal investigators, sub-investigators, study coordinators, and other clinical-trial personnel
- Ability to function in a highly regulated environment and follow RayzeBio guidelines and SOPs
- Solid understanding of GCP and ICH guidelines
- Willingness to travel approximately 30% of the time
Benefits:
- Additional incentive cash and stock opportunities (based on eligibility)
- Medical, pharmacy, dental, and vision care
- BMS Well-Being Account
- BMS Living Life Better
- Employee Assistance Programs (EAP)
- 401(k) plan
- Short- and long-term disability insurance
- Life insurance
- Accident insurance
- Supplemental health insurance
- Business travel protection
- Personal liability protection
- Identity theft benefit
- Legal support
- Survivor support
- Flexible time off for US exempt employees, with manager approval
- 11 paid national holidays
- 160 hours annual paid vacation for eligible new hires, with manager approval
- 3 optional holidays for eligible employees
- Unlimited paid sick time, based on eligibility
- Up to 2 paid volunteer days per year, based on eligibility
- Summer hours flexibility, based on eligibility
- Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
- Annual Global Shutdown between Christmas and New Years Day
- Reasonable workplace accommodations/adjustments and ongoing support
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