Director, Clinical Science

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

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 of Clinical Science plays a supportive role in clinical development of RazyeBio radiopharmaceuticals for oncology indications. Working in collaboration with clinical development, 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, collaboration on functional area activities during program implementation, 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.

• 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.

• Excellent verbal and written communication skills and interpersonal skills are required to maintain working relationship with team members to ensure scientific integrity of clinical studies.

• May be sought out for advice by others within the company to help make better decisions and resolve moderately complex problems.

Education and Experience:

• Bachelor's degree in Biological Sciences, healthcare, or a related field, with 8+ years of relevant scientific and/or drug development experience OR an MS degree with 6+ years of relevant scientific and/or drug development expe