Director of Clinical Science

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio 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 RayzeBio: https://careers.bms.com/rayzebio/

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

The Director, Clinical Science contributes to the development of RayzeBio’s pipeline across disease areas, including but not limited to hepatocellular carcinoma. Responsibilities include support for IND preparation, regulatory authority interactions, design, and execution of Phase 0 to Phase 3 clinical trials, and together with lead physician medical monitoring of ongoing studies. This role works collaboratively with multi-disciplinary 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.

The Director of Clinical Science plays a key role in clinical development of RazyeBio radiopharmaceuticals for oncology indications. Working in collaboration with clinical operations, pharmacovigilance and other functions the position is responsible for various aspects of ongoing clinical trial program-related activities within the relevant therapeutic area. These activities include, but are not limited to, clinical study start-up/execution/close out, data analysis/reporting, and potentially support of NDA/MAA filings.

Job Responsibilities:

• Acquires and utilizes knowledge of clinical trial design to develop or oversee development of specific study concept synopses and protocols.

• Participates in protocol review discussions concerning scientific and procedural aspects of study design.

• In collaboration with Medical Writing and Clinical Operations, prepares study protocols, amendments, specific sections of study manuals and Investigator meeting materials, and other documents as needed with appropriate guidance and supervision.

• Works with medical writing vendors to coordinate writing and reviewing of protocols, ICFs, IBs and other clinical trial documents as needed

• Contributes to the design, development, and review of CRFs, Data Management Manuals, and Data Analysis Plans.

• Reviews ongoing clinical data and interacts with CROs to ensure data queries are addressed and data is clean for database locks.

• Organizes and oversees Data Review Committee meetings, including preparation of slides and other review and meeting materials.

• With MD supervision, addresses questions regarding scientific and related procedural issues from Investigators. Participates in Site initiation visits and study start up activities.

• Establishes and maintains positive relationships with clinical trial investigators and site staff. Contributes to interactions with key thought leaders in gaining input on protocols and study designs and strategic direction

• Contributes to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations.

• Assists in the preparation/review of INDs, regulatory documents, IND annual report/DSURs, Investigator Brochures, and NDAs/MAAs.

• Supports priorities within functional area.

• Anticipates moderately complex obstacles within a clinical study and, with guidance, implements solutions.

• May be asked to coordinate teams and provide direction.

• May lead two or more specific components of departmental strategic initiatives.

• Able to enter a new therapeutic area and summarize scientific information that is available in published literature to integrate into new study development.

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