RayzeBio has assets in development for hepatocellular carcinoma (HCC), both as diagnostic and therapeutic, and the Clinical Development Lead will have responsibility to oversee the clinical development plans for these assets across the full range of the development lifecycle, from IND to Phase 3 registrational studies. This role will also engage with BMS oncology leaders to develop combination strategies as appropriate across the BMS and RayzeBio portfolios and support the HCC and GI disease area strategies.
Key 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 asset GPLs to ensure development and commercial optimization of RayzeBio 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 remain abreast of evolving paradigms of care and changes in the treatment landscape.
- 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.
- Lead cross-functional study teams and work collaboratively across development and commercial teams.
- Leverage AI to drive program, portfolio, or functional performance through prioritization and scaled adoption
- Supervise and mentor clinical scientists and junior MDs.
- Willing to travel approximately 30% of the time.
Education and Experience- MD with sub-specialty training in oncology and 5+ years of pharmaceutical/biotech experience in oncology solid tumor clinical development is required. Radiopharmaceutical experience is preferred but not required.
- Expertise in HCC and/or GI cancers is required.
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 on deadlines with high-performance standards and attention to detail.
- Demonstrated ability to collaborate successfully with multiple functions in a team environment.
- 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.
- Experience in all aspects of protocol conduct, 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.
- Able to function in a highly regulated environment and adhere to all RayzeBio guidelines and standard operating procedures (SOPs).
- Solid understanding of GCP and ICH guidelines.
Compensation Overview:Remote - United States - US: $306,814 - $371,787
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:
- 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.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
RayzeBio and Bristol Myers SquibbRayzeBio 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.
