Job Responsibilities:
- Define and own the diagnostic imaging portfolio strategy and target product profiles for nominated candidates, using competitive intelligence and evolving standards of care.
- Serve as imaging Clinical Development lead, providing medical/scientific direction and ensuring 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.
- Own protocol concepts and critical document content (protocols, investigator brochures, SAP inputs, clinical study reports, and key regulatory/medical communications); perform medical monitoring and data review.
- Provide medical oversight for trial conduct (eligibility/risk assessments, safety review, medical monitoring strategy, and escalation pathways with Drug Safety/Pharmacovigilance).
- Lead governance for imaging programs, including data review and IDMC/DMC activities as applicable.
- Translate research/translational/nonclinical findings into imaging development opportunities; synthesize evidence to drive go/no-go recommendations.
- Drive strategic regulatory engagement as clinical lead for health authority interactions (briefing packages, meetings, clinical rationale).
- Maintain relationships with investigators/KOLs; represent the program at scientific meetings/advisory boards.
- Work with CROs/vendors to execute radiopharmaceutical imaging clinical trials.
- Prepare briefing books, HA requests for information, and regulatory filings.
- Partner with Medical Affairs and Commercial on evidence-generation strategy and lifecycle plans.
- Contribute to resource planning, timeline/budget management, risk mitigation/contingency planning, and vendor oversight.
- Leverage AI to improve program/portfolio/functional performance through prioritization and scaled adoption.
- Travel ~30%; evening/weekend work may be required.
Qualifications/Experience:
- MD (or equivalent) with 8+ years in pharma/biotech and/or relevant academic clinical experience, including oncology diagnostic/radiopharmaceutical imaging experience through regulatory submissions.
- Demonstrated clinical development leadership; leading cross-functional teams and driving strategy.
- Experience across early- and late-phase protocol development/execution (start-up, conduct oversight, analysis inputs, reporting).
- Proven experience with investigative sites (PIs, sub-investigators, coordinators) and managing external vendors (e.g., CROs, imaging core labs).
Skills:
- Patient-focused; passion for novel radiopharmaceuticals/imaging agents.
- Strategic leader who can align stakeholders and drive decisions in a fast-paced environment.
- Ability to lead through influence in a matrix organization.
- Strong scientific judgment and benefitβrisk mindset; interpret complex imaging/clinical data.
- Executive-level written/verbal communication and presentation skills.
- Strong understanding of radiopharmaceutical imaging development, central reading, imaging endpoints, and multicenter operational considerations.
- Ability to operate in a highly regulated environment and follow RayzeBio guidelines/SOPs; solid GCP and ICH understanding.
Benefits:
- Health Coverage: Medical, pharmacy, dental, and vision care.
- Wellbeing Support: BMS Well-Being Account, BMS Living Life Better, and EAP.
- Financial Well-being and Protection: 401(k), disability, life insurance, accident/supplemental health, business travel protection, liability protection, identity theft benefit, legal support, survivor support.
Application instructions:
- None provided in the posting text.