Medical Director, Radiopharmaceutical Imaging (RPI)

Role Summary

The Medical 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 medical 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.

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.

Education

• MD or equivalent 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.

Qualifications

• 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

Additional Requirements

• Physical demands: Regularly sit, reach with hands and arms, speak and hear; occasionally lift/move up to 20 pounds; vision requirements include close and distance vision
• Work environment: Noise level typically moderate