Senior Medical Director, Radiopharmaceutical Imaging (RPI)

The Senior Medical Director, Radiopharmaceutical Imaging (RPI) provides strategic and operational leadership for the development of RayzeBio’s diagnostic imaging pipeline across disease areas, including but not limited to prostate cancer, hepatocellular cancer, and neuroendocrine tumors. This role is accountable for the imaging portfolio strategy, development plans, and key decision making from IND-enabling activities through Phase 0–Phase 3 clinical trials, including medical monitoring and benefit-risk assessments. The Senior Medical Director partners closely with cross-functional leaders (Clinical Development, Translational, Regulatory, Biomarkers, Safety, CMC, Biostatistics, Clinical Operations, Medical Affairs, and Commercial) to ensure integrated, high-quality execution, clear governance, and timely delivery of program milestones aligned with patient needs and RayzeBio’s business objectives.  

Job Responsibilities  

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

• Define and own the diagnostic imaging portfolio strategy and target product profiles for nominated candidates, incorporating competitive intelligence and evolving standards of care.  

• Serve as imaging Clinical Development lead, providing medical and scientific direction across programs and ensuring robust, decision-oriented development plans.  

• Lead and influence cross-functional matrix teams and external partners (investigators, academic collaborators, CROs, central readers) to design and execute early- and late-phase imaging studies.  

• Accountable for protocol concepts and critical document content, including protocols, investigator brochures, SAP inputs, clinical study reports, and key regulatory and medical communications. Performsmedical monitoring and data review activities in support of clinical studies 

• Provide medical oversight for trial conduct, including eligibility/risk assessments, safety review, medical monitoring strategy, and escalation pathways in collaboration with Drug Safety/Pharmacovigilance.  

• Lead governance for imaging programs, including data review activities and Independent Data Monitoring Committees (IDMCs)/Data Monitoring Committees (DMCs) as applicable.  

• Translate findings from research, translational, and nonclinical studies into imaging development opportunities and decision points; synthesize evidence to drive go/no-go recommendations.  

• Drive strategic regulatory engagement as clinical lead for health authority interactions, including briefing package strategy, participation in meetings, and representation of clinical rationale.  

• Establish and maintain strong relationships with clinical investigators and key opinion leaders; represent RayzeBio externally at scientific meetings and advisory boards as needed.  

• Work closely with CROs and vendors in the execution of clinical trials for radiopharmaceutical imaging agents 

• Participate in health authority interactions, preparation of briefing books, HA requests for information and regulatory filings. 

• Partner with Medical Affairs and Commercial to develop the evidence-generation strategy and lifecycle plans for radiopharmaceutical imaging within the broader RayzeBio portfolio.  

• Contribute to resource planning, timeline and budget management, risk mitigation/contingency planning, and vendor oversight to ensure delivery against milestones.  

• Leverages AI to drive program, portfolio, or functional performance through prioritization and scaled adoption. 

• Willing to travel approximately 30% of the time. Evening and weekend work may be required.  

Education and Experience  

• MD (or equivalent) with 8+ years of pharmaceutical/biotech and/or relevant academic clinical experience, including substantial experience in oncology diagnostic development and/or radiopharmaceutical imaging agent development through regulatory submissions  

• Demonstrated leadership in clinical development with increasing levels of responsibility, including leading cross-functional teams and driving strategy through key development decisions.  

• Experience across early- and late-phase protocol development and execution, including study start-up, oversight of conduct, analysis inputs, and reporting.  

• Proven experience working closely with investigative sites (PIs, sub-investigators, coordinators) and managing external vendors (e.g., CROs, imaging core labs). 

Skills and Qualifications  

• Patient-focused with deep commitment to improving outcomes for people with cancer and passion for developing novel radiopharmaceuticals and imaging agents.  

• Strategic clinical development leader who can set direction, align stakeholders, and drive decisions in a fast-paced, high-accountability environment.  

• Demonstrated ability to lead through influence in a matrix organization; able to build alignment across functions and levels, including senior leadership.  

• Strong scientific judgment and benefit–risk mindset; able to interpret complex imaging and clinical data and translate insights into clear development recommendations.  

• Executive-level written and verbal communication skills, including compelling presentations and the ability to represent the program effectively with health authorities and external experts.  

• Experience across early- and late-phase protocol development and execution, including study start-up, oversight of conduct, analysis inputs, and reporting.  

• Strong understanding of radiopharmaceutical imaging agent development, central reading paradigms, imaging endpoints, and operational considerations for multicenter trials.  

• Proven experience working closely with investigative sites (PIs, sub-investigators, coordinators) and managing external vendors (e.g., CROs, imaging core labs).  

• Ability to function in a highly regulated environment and to adhere to RayzeBio guidelines and standard operating procedures (SOPs).  

• Solid understanding of GCP and ICH guidelines. 

Physical Demands

While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision and distance vision.  

Work Environment  

The noise level in the work environment is usually moderate.