Director of Clinical Science

Bristol Myers Squibb • San Diego, CA

1d

About The Position

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.

Requirements

• 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 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.

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level