Associate Director, Regulatory & Safety, PET Center

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.

• 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 equipment, including GE FX, FASTlab, and comparable automated synthesis systems, as well as associated modules, consumables, and production workflows.
• Review and approve production documentation, including master production records, batch production records, equipment logs, and related quality documentation.
• Provide pharmacy oversight at the interface between radiochemistry production and clinical PET operations, ensuring that radiopharmaceuticals released for patient use meet established specifications and requirements.
• Support translation of experimental radiopharmaceutical production methods into reproducible, documented, and clinically appropriate manufacturing processes.