Position SummaryThe Head, Radiopharmaceutical Diagnostic Development will provide strategic and operational leadership for RayzeBio's diagnostic and companion imaging radiopharmaceutical portfolio, including PET and SPECT imaging agents used for patient selection, dosimetry, and disease monitoring across RayzeBio's radioligand therapy (RLT) programs (e.g., RYZ101, RYZ701, and the broader RYZ-series pipeline). This role owns the diagnostic development strategy end to end - from candidate nomination and CMC development through tech transfer, clinical supply, regulatory submission, and health authority approval - and partners closely with CMC, Quality, Regulatory Affairs, Clinical Development, Manufacturing, Isotope Supply Chain, and Commercial to ensure diagnostic agents are delivered on time, in compliance, and aligned to the needs of each therapeutic program. The role is global in scope: it is accountable for building and executing global development plans across the United States, Canada, the European Union, Australia/New Zealand, and the Asia-Pacific region, and for the ongoing lifecycle management of approved diagnostic products across all markets in which RayzeBio operates.
Job Responsibilities- Define and own the diagnostic and companion imaging development strategy across RayzeBio's portfolio, aligning imaging agent timelines with the therapeutic programs they support.
- Build and execute global development plans for diagnostic radiopharmaceuticals, coordinating regulatory strategy, filings, and market entry across the United States, Canada, the European Union, Australia/New Zealand, and the Asia-Pacific region.
- Own lifecycle management for approved diagnostic products, including post-approval changes, label updates, supplemental filings, manufacturing changes, and continued market compliance across all regions in which the products are marketed.
- Tailor regional regulatory and CMC strategies to align with local health authority requirements (e.g., FDA, Health Canada, EMA, TGA, and APAC regulatory bodies) while maintaining a unified global development plan.
- Lead CMC strategy, process development, and validation for diagnostic radiopharmaceuticals, including radiosynthesis, radiolabeling, and quality control methods for isotopes such as Ga-68, F-18, and Cu-64.
- Direct technology transfer and scale-up of diagnostic manufacturing processes across internal sites and third-party CDMOs/CROs, ensuring robust, reproducible, and inspection-ready operations.
- Serve as the primary strategic point of contact with FDA and other health authorities for diagnostic imaging agent submissions, meetings, and inspections, including IND, NDA, and ANDA filings.
- Author and oversee CMC sections, briefing documents, and regulatory correspondence for diagnostic development programs; lead health authority interactions in partnership with Regulatory Affairs.
- Partner with Clinical Development and Translational Medicine to design imaging strategies that support patient selection, dosimetry, and biomarker objectives for RLT clinical trials.
- Build, mentor, and lead a high-performing team of scientists and CMC/regulatory professionals supporting diagnostic development.
- Ensure diagnostic development activities comply with 21 CFR Parts 211 and 212, USP , NRC requirements, and other applicable radiopharmaceutical regulations.
- Manage external supplier, CDMO, and CRO relationships supporting diagnostic manufacturing, analytical testing, and clinical supply.
- Represent RayzeBio externally with industry and standards bodies (e.g., SNMMI, MITA, USP) to help shape evolving standards for diagnostic radiopharmaceuticals.
- Own budget, resourcing, and risk mitigation planning for the diagnostic development function; report progress and risks to senior leadership.
- Identify opportunities to apply digital tools and AI to improve development speed, data integrity, and decision-making across diagnostic programs.
- Willing to travel approximately 20-30% of the time; occasional evening or weekend work may be required to support inspections or health authority interactions.
Education and Experience- PharmD, PhD, or other advanced scientific degree, with 10+ years of experience in radiopharmaceutical, PET/SPECT diagnostic, or nuclear medicine product development, or an equivalent combination of education and experience.
- Demonstrated success leading CMC and regulatory strategy for diagnostic or companion imaging radiopharmaceuticals through IND-enabling activities and NDA/ANDA approval.
- Hands-on experience with cGMP radiopharmaceutical manufacturing, including cyclotron- or generator-produced isotopes and automated radiosynthesis platforms.
- Track record of leading successful FDA inspections (including pre-approval inspections) and direct health authority interactions.
- Prior people-leadership experience managing cross-functional scientific, regulatory, and/or quality teams.
- Experience building and executing global development and regulatory plans across multiple regions (e.g., US, Canada, EU, Australia/New Zealand, APAC), including lifecycle management of approved products.
- Deep subject-matter expertise in PET/SPECT diagnostic radiopharmaceutical development, manufacturing, and regulatory pathways.
- Strong understanding of companion diagnostic strategy and how imaging agents support patient selection for radioligand therapy programs.
- Proven ability to lead through influence in a matrix organization, building alignment across functions and with senior leadership.
- Strong scientific and regulatory judgment, with the ability to translate complex CMC and clinical data into clear, decision-oriented recommendations.
- Executive-level written and verbal communication skills, including experience representing programs to FDA, investigators, and industry bodies.
- Ability to operate effectively in a highly regulated environment and adhere to RayzeBio's guidelines and standard operating procedures (SOPs).
- Patient-focused, with a genuine commitment to improving outcomes for people with cancer through innovative radiopharmaceuticals.
- Working knowledge of international regulatory frameworks and health authority expectations across North America, Europe, Australia/New Zealand, and the Asia-Pacific region, and experience managing product lifecycle activities on a global scale.
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We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.
Compensation Overview:Remote - United States - US: $221,749 - $268,707
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
RayzeBio and Bristol Myers SquibbRayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.
