Director, Radiopharmaceutical Imaging (RPI)

Bristol Myers Squibb • San Diego, CA

15d • $210,572 - $275,577

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 RPI has responsibility for the development of RayzeBio’s diagnostic imaging pipeline across disease areas, including but not limited to prostate cancer, hepatocellular cancer and neuroendocrine tumors. Responsibilities may include support for IND preparation, regulatory authority interactions, design, and execution of Phase 0 to Phase 3 clinical trials, and medical monitoring. This role provides clinical direction and high quality scientific and clinical knowledge to guide the strategy and execution of RayzeBio’s diagnostic imaging portfolio. 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.

Requirements

• Advanced degree in life sciences (eg Pharm D, PhD, MSc) with at least 5 years of pharmaceutical, biotech experience or academic clinical experience in oncology diagnostic development or 3 years’ experience for candidates with track record of developing radiopharmaceutical imaging agents through a regulatory process.
• Patient-focused, with deep commitment to understanding needs and improving the lives of patients with cancers and a passion for developing novel therapeutics
• Motivated to work in a fast-paced, high accountability, and small company environment.
• A "can do" and collegial professional who leads through influence and interpersonal skills.
• Demonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering deadlines with high performance standards and attention to detail.
• Demonstrated ability to collaborate successfully with multiple functions in a team environment.
• Intellectually curious with courage to challenge and seek new ways to improve work.
• Strong written and oral communication skills, including presentation skills.
• Ability to analyze and interpret data and develop written reports and presentations of those data.
• Strong critical, strategic, and analytical thinking skills.
• Experience in all aspects of protocol conduct, both early and late phase, including protocol writing, start-up, study execution, analysis, and reporting.
• Experience working closely with investigative sites, including principal investigators, sub- investigators, study coordinators, and other site personnel involved in clinical trials.
• Skilled in clinical research and understands the process of radiopharmaceutical imaging agent development and approval.
• Able to function in a highly regulated environment and to adhere to all RayzeBio guidelines and standard operating procedures (SOP’s).
• Solid understanding of GCP and ICH guidelines.

Responsibilities

• Interact with clinical investigators and thought leaders to design a diagnostic imaging strategic plan for nominated candidates
• Lead internal project teams, and partner with investigators and CROs to design and implement clinical studies of radiopharmaceutical imaging agents.
• Contribute to writing of protocols, investigator brochures, clinical study reports, and review of other clinical trial and regulatory documents
• Conduct investigator meetings and lead site qualification and initiation visits with clinical trial investigators
• Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets
• Translate findings from research and nonclinical studies into diagnostic imaging development opportunities
• Oversee Data Review and Independent Data Monitoring Committees as applicable
• Conduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines
• Establish and maintain positive relationships with clinical trial investigators and thought leaders
• Serve as clinical lead for regulatory interactions, including preparation of briefing documents and attendance and presentation at health authority meetings.
• Work closely with commercial and medical affairs organization to develop and execute on a diagnostic imaging program for RayzeBio portfolio in radiopharmaceutical imaging.
• Willing to travel approximately 30% of the time.
• Evening and weekend work will be involved.

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.
• 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.

What This Job Offers

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