Therapeutic Strategy Lead

Summary

Join PSI as a part-time Therapeutic Strategy Lead (Radiopharmacist) for a 6-month contract, working remotely in the United States. Support the strategic development of PSI's radiopharmaceutical clinical trials by providing subject matter expertise on radiopharmacy practices and regulations. Responsibilities include supporting study design, site evaluation, project planning, and risk mitigation related to radiopharmacy operations. You will also contribute to business development by serving as a radiopharmacy SME in discussions with sponsors and partners. This role requires a pharmacy degree with nuclear pharmacist licensure or equivalent, relevant certifications, and prior radiopharmacist experience. Knowledge of radiopharmaceutical production, handling, transport, and regulatory considerations is essential.

Requirements

• Degree in Pharmacy or related field with licensure as a nuclear pharmacist or equivalent
• Certification or training relevant to radiopharmaceutical handling and safety (e.g., board certification, radiation safety certifications) required
• Prior experience working as a radiopharmacist is required
• Knowledge of radiopharmaceutical production, handling, transport, and regulatory considerations in clinical or commercial environments
• Familiarity with Good Manufacturing Practice (GMP), radiation safety, and applicable regulatory guidance

Responsibilities

• Provide expert input on radiopharmaceutical processes, compliance, handling, and regulatory aspects to support protocol development and operational planning
• Support the evaluation of radiopharmacy capabilities at potential investigative sites
• Review and advise on radiopharmaceutical aspects of essential study documents and technical manuals
• Assist with identification and mitigation of study risks related to radiopharmacy operations
• Participate in internal project meetings and key discussions with external partners, providing radiopharmacy guidance
• Contribute background research on radiopharmaceuticals, including regulatory landscape, manufacturing, and logistics
• Support training and knowledge-sharing initiatives related to radiopharmacy within the study team
• Serve as a radiopharmacy SME in discussions with potential sponsors and partners
• Contribute to proposal development and bid defense activities as needed
• Represent PSI’s radiopharmacy expertise to internal and external stakeholders
• Assist in the development and maintenance of PSI’s network of radiopharmacy experts and facilities