Senior Medical Director, Clinical Development – Radiopharmaceuticals, HCC and GI Cancers

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the clinical development plans for hepatocellular carcinoma assets throughout the development lifecycle, from IND to Phase 3 registrational studies.

• Collaborate with BMS oncology leaders to formulate combination strategies across both BMS and RayzeBio portfolios.

• Assist in the strategies for HCC and GI disease areas.

• Aid in the preparation of IND submissions and interactions with regulatory authorities.

• Design and implement clinical trials ranging from Phase 1 to Phase 3.

• Provide medical monitoring for clinical studies.

• Lead cross-functional study teams tasked with study design, execution, monitoring, analysis, and reporting.

• Engage with clinical investigators and thought leaders to craft clinical development plans.

• Partner with investigators and CROs to design and execute clinical studies.

• Collaborate with asset GPLs to optimize development and commercial strategies.

• Contribute to the creation of protocols, investigator brochures, clinical study reports, and other essential clinical trial and regulatory documents.

• Conduct investigator meetings and lead site qualification and initiation visits.

• Implement strategic drug-development plans and formulate contingency strategies.

• Translate research and nonclinical findings into viable clinical development opportunities.

• Oversee Data Review and Independent Data Monitoring Committees.

• Ensure compliance of clinical trials with pharmaceutical-industry ethical standards and external regulatory requirements.

• Cultivate relationships with clinical investigators and thought leaders.

• Lead regulatory interactions, including the preparation of briefing documents and health-authority meetings.

• Collaborate with various development and commercial teams.

• Utilize AI to enhance program, portfolio, or functional performance.

• Supervise and mentor clinical scientists and junior MDs.

⛳️ Requirements

• MD with sub-specialty training in oncology is required.

• A minimum of 5 years of experience in pharmaceutical/biotech oncology solid-tumor clinical development is required.

• Expertise in HCC and/or GI cancers is required.

• Experience with radiopharmaceuticals is preferred, though not mandatory.

• A patient-focused commitment to enhancing outcomes for individuals with cancer is essential.

• Ability to thrive in a fast-paced, high-accountability, small-company setting.

• Proven track record of accomplishments in a compressed timeframe.

• Capability to prioritize tasks and meet deadlines while maintaining high-performance standards and attention to detail.

• Demonstrated ability to collaborate across various functions.

• Strong skills in written, oral, and presentation communication.

• Excellent critical, strategic, and analytical thinking abilities.

• Experience in protocol writing, study initiation, execution, analysis, and reporting.

• Familiarity with working alongside investigative sites, principal investigators, sub-investigators, study coordinators, and other clinical trial personnel.

• Ability to operate within a highly regulated environment and adhere to 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).

• Comprehensive medical, pharmacy, dental, and vision care.

• BMS Well-Being Account.

• BMS Living Life Better program.

• Employee Assistance Programs (EAP).

• 401(k) retirement plan.

• Short- and long-term disability insurance.

• Life insurance coverage.

• Accident insurance options.

• Supplemental health insurance.

• Business travel protection.

• Personal liability protection.

• Identity theft protection benefit.

• Legal support services.

• Survivor support programs.

• Flexible time off for US exempt employees, subject to manager approval.

• 11 paid national holidays.

• 160 hours of annual paid vacation for eligible new hires, with manager approval.

• 3 optional holidays available for eligible employees.

• Unlimited paid sick time based on eligibility.

• Up to 2 paid volunteer days per year, depending on eligibility.

• Summer hours flexibility, contingent on eligibility.

• Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs.

• Annual Global Shutdown between Christmas and New Year's Day.

• Reasonable workplace accommodations and ongoing support.