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 youll 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 impacton our science on our teams and most importantly on patients. Learn more about 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 RayzeBios 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 RayzeBios portfolio to ensure the program meets the needs of patients and RayzeBios 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.

• 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:

• Bachelors 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 experience.

• Or PharmD or PhD with 5 years of experience in clinical research or clinical pharmacology in a biotech/pharmaceutical company contract research organization or academic institution.

• Demonstrated ability to be a fast learner.

• Demonstrated ability to be flexible and adaptable to change to move between projects easily and provide support/expertise where needed.

• Experienced with Microsoft Office (Excel PowerPoint etc.) as well as job-related programs such as SpotFire.

• Knowledge of FDA EMA and ICH regulations and guidelines.

• Ability to effectively collaborate cross-functionally across all levels of the organization.

Physical demands:

While performing the duties of this job the employee is regularly required to sit reach with hands and arms and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision and distance vision.

Work Environment:

The noise level in the work environment is usually moderate.

If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

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 employees 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 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 Squibb

RayzeBio 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.

Supporting People with Disabilities

BMS and RayzeBio are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application or in any part of the recruitment process direct your inquiries to. Visit access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS and RayzeBio will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information: Protection

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