Associate Director/Director Clinical Science

Job Title: Associate/Director, Clinical Science

Location: Remote

ID: R12

Background

RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio will operate as a standalone entity within the BMS organization, maintaining its biotech culture with the opportunity to leverage the best-in-class oncology capabilities of BMS. RayzeBio is developing innovative drugs against targets of solid tumors. The lead asset, RYZ101, is in Phase 3 testing for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), as well as earlier stage testing for patients with small cell lung cancer (SCLC). Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

Summary

The Associate/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

Essential duties and responsibilities include the following. Other duties may be assigned.

• 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.

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

• Reviews ongoing clinical data.

• 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.

• 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.

• 20% of travel required

Education and Experience

• PharmD or PhD preferred

• 6+ years of relevant scientific and/or drug development experience with a MS (8+ for director level).

• 8+ years of relevant scientific and/or drug development experience with a BS degree in Biological Sciences, health care, or a related field (10+ for director level).

• 3-5 years experience (3 for associate director.; 5 for director) in clinical research or clinical pharmacology in a biotech/pharmaceutical company, contract research organization, or academic institution.

The starting compensation for this job is a range from $167,612 to $275,867, plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.

Final, individual compensation will be decided based on demonstrated experience.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Employee assistance programs (EAP) and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance and supplemental health insurance. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, and sick time off. Parental, caregiver, bereavement, and military leave. Other perks like tuition reimbursement.