Medical Director, Radiopharmaceutical Imaging; RPI

Overview

Rayze Bio, a Bristol Myers Squibb company
, is a dynamic biotechnology company focused on improving survival of people with cancer by harnessing the power of targeted radiopharmaceuticals. The Medical Director, Radiopharmaceutical Imaging, has responsibility for the development of Rayze Bio's diagnostic imaging pipeline across disease areas including prostate cancer, hepatocellular carcinoma, and neuroendocrine tumors. Responsibilities may include support for IND preparation, regulatory authority interactions, and the design and execution of Phase 0 to Phase 3 clinical trials, with medical monitoring.

This role provides medical direction and high-quality scientific and clinical knowledge to guide strategy and execution of Rayze Bio’s diagnostic imaging portfolio. The role collaborates with multidisciplinary teams responsible for design, implementation, monitoring, analysis, and reporting of studies to ensure patient needs and Rayze Bio’s business goals are met.

• 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 in accordance with ethical guidelines and regulatory requirements
• 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/presentation at health authority meetings
• Collaborate with commercial and medical affairs to develop and execute a diagnostic imaging program for Rayze Bio
• Travel approximately 30% of the time; evening and weekend work may be required

• MD or equivalent with at least 5 years of pharmaceutical/biotech experience or academic clinical experience in oncology diagnostic development, or 3 years for candidates with a track record of developing radiopharmaceutical imaging agents through regulatory processes

• Patient-focused with a deep commitment to improving lives of patients with cancer and a passion for developing novel therapeutics
• Ability to thrive in a fast-paced, high-accountability, small-company environment; strong influence and interpersonal skills
• Proven ability to prioritize and deliver in compressed timelines with high performance standards
• Collaborative approach across multiple functions; strong written and oral communication, including presentations
• Analytical mindset with ability to interpret data and develop reports and presentations
• Strong critical, strategic, and analytical thinking
• Experience across all phases of protocol conduct, including start-up, execution, analysis, and reporting
• Experience working with investigative sites, PIs, sub-investigators, study coordinators, and site personnel
• Knowledge of radiopharmaceutical imaging agent development and approvals; ability to operate in a regulated environment and adhere to SOPs
• Solid understanding of GCP and ICH guidelines

Regularly sit, reach with hands and arms, talk or hear. May occasionally lift/move up to 20 pounds. Close and distance vision required.

The noise level is usually moderate. See company policy for on-site, hybrid, or remote work arrangements.

Remote - United States: $265,740 – $322,014;
San Diego, CA: $286,999 – $347,775. Final compensation will reflect experience. Benefits vary by location and eligibility. See careers site for details:

With Transforming patients  lives through science as our vision, every BMS employee plays an integral role in work that goes beyond ordinary. We value passion, innovation, urgency, accountability, inclusion, and integrity.

On-site/occupancy model determines where work is performed. Site-essential roles require 100% onsite; hybrid roles require at least 50% onsite; field/remote roles may require travel. We are committed to supporting applicants with disabilities. For accommodations, contact  Equal Employment Opportunity information available at

R1597090 Medical Director, Radiopharmaceutical Imaging