Associate Director, Regulatory & Safety, PET Center
Listed on 2026-09-20
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Healthcare
Healthcare Compliance, Healthcare Management
Associate Director, Regulatory & Safety, PET Center
Position Title Associate Director, Regulatory & Safety
Working Title Associate Director, Regulatory & Safety, PET Center
Profession Pharmacist (PharmD)
Department Radiology, Division of Molecular Imaging and Therapeutics Research
Center Columbia University PET Center
Reports To Director, PET Center
Location Columbia University Irving Medical Center
Position Type Full-time
Appointment Posted at all faculty ranks (Assistant to Associate Professor), commensurate with experience
Salary Range $190,000-$215,000
The Associate Director, Regulatory & Safety, PET Center is a pharmacist (PharmD) who provides leadership and operational oversight for radiopharmaceutical production, quality control, dispensing, and clinical PET imaging, and serves as a key institutional resource for patient safety, quality assurance, GMP manufacturing, regulatory affairs, and FDA compliance.
The position operates at the intersection of clinical nuclear medicine, radiochemistry, radiopharmaceutical manufacturing, radiation safety, and regulatory affairs. The successful candidate will have experience with radiopharmaceutical production and clinical PET operations and will possess a strong understanding of FDA and other federal and state regulatory requirements governing radioactive materials, radiopharmaceuticals, and investigational drug products, including documentation of manufacturing processes, quality-control testing, batch records, deviations, corrective and preventive actions, and preparation for regulatory inspections.
The role carries primary responsibility for maintaining regulatory and quality systems for the PET Center and serves as a principal point of contact for FDA inspections, radioactive-material licensing, radiopharmaceutical regulatory requirements, and institutional quality and safety programs.
The Associate Director will work closely with radio chemists, nuclear medicine physicians, PET Center leadership, medical physicists, radiation safety personnel, research investigators, quality personnel, and institutional regulatory offices to ensure that radiopharmaceuticals are produced and administered safely, consistently, and in compliance with applicable regulatory and institutional requirements.
This position represents an opportunity to help build and establish a state-of-the-art academic PET and radiopharmaceutical program supporting clinical care, translational research, and development of novel radiopharmaceuticals.
Key Responsibilities Clinical PET and Radiopharmaceutical Operations- Provide pharmacy expertise and operational oversight for clinical PET radiopharmaceutical procurement, receipt, storage, preparation, dispensing, and administration.
- Collaborate with nuclear medicine physicians, technologists, and other clinical personnel to ensure timely and appropriate availability and use of radiopharmaceuticals for clinical and research imaging.
- Develop and implement SOPs and quality processes for clinical radiopharmaceutical operations.
- Provide leadership for patient-safety and quality-assurance processes related to radiopharmaceutical preparation, dispensing, administration, and clinical PET operations.
- Support integration of new radiopharmaceuticals and imaging agents into clinical practice.
- Provide pharmacy and manufacturing expertise for production of PET radiopharmaceuticals in accordance with applicable FDA, USP, institutional, and radiation-safety requirements.
- Work closely with radio chemists and production personnel on development, validation, optimization, and implementation of radiopharmaceutical manufacturing processes.
- Maintain technical familiarity with automated radiochemistry synthesis…
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