Head, Global Radiopharmaceutical Diagnostic Development
Bristol Myers Squibb
September 03, 2026
Remote
United States
Clinical Research and Development
Position Summary
The Head, Radiopharmaceutical Diagnostic Development provides strategic and operational leadership for RayzeBio’s diagnostic and companion imaging radiopharmaceutical portfolio (PET/SPECT imaging agents) across radioligand therapy (RLT) programs. Owns the diagnostic development strategy end to end (candidate nomination through CMC, tech transfer, clinical supply, regulatory submission, health authority approval) and partners cross-functionally to deliver diagnostic agents on time and in compliance. Global scope with lifecycle management across the US, Canada, EU, Australia/NZ, and Asia-Pacific.
Job Responsibilities
- Define and own diagnostic/companion imaging development strategy; align imaging timelines with therapeutic programs.
- Build and execute global development plans; coordinate regulatory strategy, filings, and market entry.
- Own lifecycle management for approved diagnostic products (changes, label updates, supplemental filings, manufacturing changes, compliance).
- Tailor regional regulatory/CMC strategies to local requirements while maintaining a unified global plan.
- Lead CMC strategy, process development, and validation (radiosynthesis, radiolabeling, QC) for isotopes (Ga-68, F-18, Cu-64).
- Direct technology transfer and scale-up (internal sites and CDMOs/CROs).
- Primary point of contact for FDA and other authorities for submissions, meetings, and inspections (IND/NDA/ANDA).
- Author/oversee CMC and regulatory correspondence; lead health authority interactions with Regulatory Affairs.
- Partner with Clinical Development/Translational Medicine to design imaging strategies (patient selection, dosimetry, biomarkers).
- Build and lead the team.
- Ensure compliance with applicable radiopharmaceutical regulations (e.g., 21 CFR Parts 211/212).
- Manage external supplier/CDMO/CRO relationships.
- Represent the company with industry standards bodies (e.g., SNMMI, MITA, USP).
- Own budget/resourcing/risk mitigation; report to senior leadership.
- Identify opportunities to apply digital tools/AI.
- Travel ~20–30%.
Education And Experience / Qualifications
- PharmD/PhD or advanced degree; 10+ years in radiopharmaceutical/PET-SPECT/nuclear medicine diagnostic development (or equivalent).
- Proven success leading CMC/regulatory strategy for diagnostic/companion imaging agents (IND-enabling through NDA/ANDA approval).
- Hands-on cGMP radiopharmaceutical manufacturing experience (cyclotron/generator isotopes; automated radiosynthesis).
- Track record leading FDA inspections (including pre-approval) and direct health authority interactions.
- Prior people leadership across scientific/regulatory/quality teams.
- Experience executing global development/regulatory plans across multiple regions, including product lifecycle management.
- Deep expertise in PET/SPECT diagnostic radiopharmaceutical development/manufacturing/regulatory pathways.
- Strong understanding of companion diagnostics and imaging for radioligand therapy patient selection.
- Matrix leadership; strong scientific and regulatory judgment.
- Executive communication skills; represent programs to FDA/investigators/industry.
- Ability to operate in highly regulated environments and follow SOPs.
- Patient-focused commitment.
- Working knowledge of international regulatory frameworks and health authority expectations.
Benefits (only if explicitly listed)
- Health coverage (medical, pharmacy, dental, vision); wellbeing support; 401(k); short- and long-term disability; life and accident insurance; supplemental health; business travel protection; personal liability; identity theft benefit; legal support; survivor support.
- Paid time off: flexible time off for US exempt employees; 160 hours annual paid vacation (Phoenix, PR, and RayzeBio exempt non-exempt/hourly) plus holidays.
Application instructions
- Apply for R1605327: Head, Radiopharmaceutical Diagnostic Development.
The Head, Radiopharmaceutical Diagnostic Development provides strategic and operational leadership for RayzeBio’s diagnostic and companion imaging radiopharmaceutical portfolio (PET/SPECT imaging agents) across radioligand therapy (RLT) programs. Owns the diagnostic development strategy end to end (candidate nomination through CMC, tech transfer, clinical supply, regulatory submission, health authority approval) and partners cross-functionally to deliver diagnostic agents on time and in compliance. Global scope with lifecycle management across the US, Canada, EU, Australia/NZ, and Asia-Pacific.
Job Responsibilities
- Define and own diagnostic/companion imaging development strategy; align imaging timelines with therapeutic programs.
- Build and execute global development plans; coordinate regulatory strategy, filings, and market entry.
- Own lifecycle management for approved diagnostic products (changes, label updates, supplemental filings, manufacturing changes, compliance).
- Tailor regional regulatory/CMC strategies to local requirements while maintaining a unified global plan.
- Lead CMC strategy, process development, and validation (radiosynthesis, radiolabeling, QC) for isotopes (Ga-68, F-18, Cu-64).
- Direct technology transfer and scale-up (internal sites and CDMOs/CROs).
- Primary point of contact for FDA and other authorities for submissions, meetings, and inspections (IND/NDA/ANDA).
- Author/oversee CMC and regulatory correspondence; lead health authority interactions with Regulatory Affairs.
- Partner with Clinical Development/Translational Medicine to design imaging strategies (patient selection, dosimetry, biomarkers).
- Build and lead the team.
- Ensure compliance with applicable radiopharmaceutical regulations (e.g., 21 CFR Parts 211/212).
- Manage external supplier/CDMO/CRO relationships.
- Represent the company with industry standards bodies (e.g., SNMMI, MITA, USP).
- Own budget/resourcing/risk mitigation; report to senior leadership.
- Identify opportunities to apply digital tools/AI.
- Travel ~20–30%.
Education And Experience / Qualifications
- PharmD/PhD or advanced degree; 10+ years in radiopharmaceutical/PET-SPECT/nuclear medicine diagnostic development (or equivalent).
- Proven success leading CMC/regulatory strategy for diagnostic/companion imaging agents (IND-enabling through NDA/ANDA approval).
- Hands-on cGMP radiopharmaceutical manufacturing experience (cyclotron/generator isotopes; automated radiosynthesis).
- Track record leading FDA inspections (including pre-approval) and direct health authority interactions.
- Prior people leadership across scientific/regulatory/quality teams.
- Experience executing global development/regulatory plans across multiple regions, including product lifecycle management.
- Deep expertise in PET/SPECT diagnostic radiopharmaceutical development/manufacturing/regulatory pathways.
- Strong understanding of companion diagnostics and imaging for radioligand therapy patient selection.
- Matrix leadership; strong scientific and regulatory judgment.
- Executive communication skills; represent programs to FDA/investigators/industry.
- Ability to operate in highly regulated environments and follow SOPs.
- Patient-focused commitment.
- Working knowledge of international regulatory frameworks and health authority expectations.
Benefits (only if explicitly listed)
- Health coverage (medical, pharmacy, dental, vision); wellbeing support; 401(k); short- and long-term disability; life and accident insurance; supplemental health; business travel protection; personal liability; identity theft benefit; legal support; survivor support.
- Paid time off: flexible time off for US exempt employees; 160 hours annual paid vacation (Phoenix, PR, and RayzeBio exempt non-exempt/hourly) plus holidays.
Application instructions
- Apply for R1605327: Head, Radiopharmaceutical Diagnostic Development.