Director of Pharmacovigilance (US)
About the role
ITM is a privately owned biotechnology and radiopharmaceutical group of companies dedicated to the development, production and global supply of targeted diagnostic and therapeutic radiopharmaceuticals and radioisotopes for use in cancer treatment. We are developing a proprietary portfolio and growing pipeline of targeted treatments in various stages of clinical development addressing cancers such as neuroendocrine cancers or bone metastases. Our main objectives are to significantly improve treatment outcomes and quality of life for cancer patients through a new generation of Targeted Radionuclide Therapies in Precision Oncology. The headquarters are located in the heart of the research center of the Technical University of Munich (TUM). In the United States, ITM is expanding to support our growing portfolio and pipeline. We are building a high-performing commercial team to bring innovative radiopharmaceutical therapies to patients and strengthen our presence in oncology.
Responsibilities
- Operate within a globally centralized PV framework led from EU headquarters, ensuring US alignment with global strategy, processes, and governance
- Act as the primary US interface to global PV leadership and QPPV Office, promoting a “one PV organization” mindset
- Ensure US requirements are integrated into global activities without duplication or regional divergence
- Establish and maintain a compliant, inspection-ready US PV set-up, aligned with global systems and adapted to FDA requirements
- Ensure appropriate execution of US-specific PV obligations, acting as the accountable local representative within the global model
- Serve as the primary PV contact for FDA, supporting inspections and regulatory interactions
- Operate with a hands-on approach during the first 12–24 months, directly supporting key PV activities as needed
- Maintain strong oversight and awareness of global activities, ensuring US regulatory nuances and timelines are appropriately addressed
- Contribute to global processes through US regulatory expertise, including input into case handling, reporting requirements, and signal evaluation
- Execute locally required PV tasks (e.g., US-specific submissions, local regulatory commitments, REMS/RMP components where applicable, local vendor management and oversight)
Requirements
Advanced degree in Life Sciences, Pharmacy, or Medicine (PharmD/MD/PhD preferred) 10+ years in Pharmacovigilance, including senior leadership experience Strong expertise in FDA PV requirements, with solid knowledge of EMA/ICH Proven experience in global/matrix environments, with close collaboration with EU headquarters Demonstrated ability to build or scale PV capabilities in biotech settings Experience with regulatory inspections and authority interactions (FDA) Strong global mindset—you prioritize alignment over regional autonomy Ability to lead hands-on while building for scale Skilled in influencing across regions and functions Comfortable operating within centrally governed, globally distributed models
Qualifications
Qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, age, national origin, disability, veteran status, marital status, or any other characteristic protected by law. If you are a qualified individual with a disability or a disabled veteran and are unable to apply for a position through our online application process, you may request a reasonable accommodation. To request assistance, please contact us at careersus@itm-radiopharma.com.
Skills
Not specified
Benefits
Comprehensive health benefits, including a medical plan with no employee premium and 100% company-paid dental and vision coverage. Annual bonus opportunity. 401(k) with company match. Generous paid time off and company holidays. An entrepreneurial environment with the opportunity to shape a high-growth U.S. business.
Pay
$225,000 - $260,000
Schedule
Hybrid working model in Princeton