Study Start-Up Manager- Nuclear Medicine Oversight (Remote Position)

Role Summary

This role provides strategic and operational support for the implementation of clinical studies involving Radioligand Therapy (RLT) across the United States. While framed as a Study Start-Up (SSU) Manager, it does not include regulatory or traditional study-management responsibilities. The role serves as a dedicated resource to expand and enable RLT studies, considering varying levels of experience and readiness across the region. The position is remote within the United States.

Responsibilities

• Support the mapping and structuring of Central Radiopharmacies in the US, including vendor qualification and contract negotiation support.
• Support the contracting of specialized vendors and provide legal coordination for technical agreements and contracts.
• Act as a regional point of contact for nuclear medicine infrastructure, including equipment, suppliers, and radiolabeling processes.
• Collaborate with local and global stakeholders to ensure the technical and operational feasibility of RLT studies.
• Identify gaps and propose solutions to enhance the country’s readiness and capacity for conducting radiopharmaceutical studies.
• Assist studies in securing RLT supplies, supporting with vendor process excellence during Study Start-Up (SSU) and throughout trial conduct.
• Partner with SSU, Clinical Operations, Legal, Quality, Procurement and Regulatory Affairs teams, without assuming direct responsibilities from these areas.
• Contribute to the development of regional playbooks, procedures and best practices for RLT studies.
• Oversight of selection, qualification, and management of RP (central and site) activities.
• Oversight of management of nuclear medicine equipment related tasks (i.e., Dose Calibrator calibrations, Gamma Counter calibrations, SPECT/CT qualifications, PET/CT qualifications, procurement of equipment).

Qualifications

• BS/BA Degree in Pharmacy, Biomedicine, Biomedical Engineering, Medical Physics, or related fields.
• Solid knowledge of radiopharmacy and nuclear medicine, including cold kit radiolabeling processes and operation of equipment such as gamma cameras, PET/CT, and hot cells.
• Familiarity with local and international regulations applicable to radiopharmaceuticals.
• Experience in mapping and qualifying technical and logistical vendors for radiopharmaceutical studies.
• Understanding of importation, transportation, and storage processes for radioactive materials.
• Ability to read and interpret technical documents, including product dossiers, safety data sheets, clinical protocols, and technical contracts.
• Basic knowledge of compliance and quality standards relevant to clinical studies involving radioactive products.
• Strong stakeholder management skills with technical profiles, including clinical engineers, medical physicists, pharmacists, and nuclear medicine specialists.