Sr Medical Director Clinical Development - Radiopharmaceuticals HCC and GI cancers Remote

Position: Sr Medical Director Clinical Development - Radiopharmaceuticals HCC and GI cancers Remote - Uni[...]
## Sr Medical Director Clinical Development
- Radiopharmaceuticals HCC and GI cancersRemote
- United States - USFind out how well you match with this jobAt Rayze Bio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, Rayze Bio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer.

Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about Rayze Bio: 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 Rayze Bio 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 Rayze Bio’s portfolio to ensure the program meets the needs of patients and Rayze Bio’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 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 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…