Senior Medical Director, Radiopharmaceutical Imaging (RPI)
About the role
The Senior Medical Director, Radiopharmaceutical Imaging (RPI) at RayzeBio 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.
Responsibilities
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.
Perform medical 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.
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.
Leverage 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.
Requirements
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).
Qualifications
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.
Skills
Strategic clinical development leader who can set direction, align stakeholders, and drive decisions in a fast-paced, high-accountability environment.
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.
Benefits
RayzeBio offers a comprehensive benefits package including:
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.