About ITM
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.
We are seeking a highly experienced Director / Head of Pharmacovigilance (US) to establish and lead our US PV presence within a globally integrated, EU‑headquartered pharmacovigilance organization.
This role is critical in ensuring that US regulatory requirements are effectively implemented within a globally led PV system, without creating a standalone or siloed US function. The successful candidate will act as a key bridge between the US and EU headquarters, ensuring alignment, consistency, and compliance across regions.
During the initial 12–24 months, this role requires a hands-on leader who can both build the function and contribute operationally, in close collaboration with the Global PV/QPPV Office.
We would like to fill the following permanent vacancy in a hybrid working model in Princeton as soon as possible
Director of Pharmacovigilance (US)
Your role
Global Integration & Governance
- 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
US PV Implementation
- Establish and maintain a compliant, inspection-ready US PV set-up, aligned with global systems and adapted to FDA requiements
- 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
Operational Contribution (Globally Led Model)
- Work within a structure where core PV activities (case processing, signal detection, aggregate reporting) are led by EU/global teams
- 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)
Hands-On Leadership (Build Phase)
- Operate with a hands-on approach during the first 12–24 months, directly supporting key PV activities as needed
- Collaborate closely with EU/global teams to implement processes, address gaps, and ensure operational continuity
- Gradually transition toward a strategic oversight role as the US function and team mature
Team Building & Cross-Functional Leadership
- Build and develop a lean, high-performing US PV team, fully integrated into the global organization
- Partner with stakeholders across Clinical, Regulatory, Medical Affairs, and Quality in both US and EU
- Actively contribute to global PV initiatives and continuous improvement efforts
Your profile
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Advanced degree in Life Sciences, Pharmacy, or Medicine (PharmD/MD/PhD preferred)
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10+ years in Pharmacovigilance, including senior leadership experience
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Strong expertise in FDA PV requirements, with solid knowledge of EMA/ICH
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Proven experience in global/matrix environments, with close collaboration with EU headquarters
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Demonstrated ability to build or scale PV capabilities in biotech settings
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Experience with regulatory inspections and authority interactions (FDA)
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Strong global mindset—you prioritize alignment over regional autonomy
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Ability to lead hands-on while building for scale
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Skilled in influencing across regions and functions
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Comfortable operating within centrally governed, globally distributed models
Our offer
- Competitive base salary.
- 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.
Salary Range (US) $225,000 - $260,000
The compensation range for this US role is listed above for a full-time employee. Actual salary will vary based on factors such as candidate's qualifications, skills, competencies, and demonstrated experience.
ITM is an equal opportunity employer. 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.
Contact
ITM Isotope Technologies Munich SE
Human Resources
Walther-von-Dyck-Str. 4
85748 Garching/München, Deutschland
Note for recruitment agencies
Please note that we do not accept unsolicited applications or offers of assistance. The telephone number given in the advertisement is intended exclusively for applicants and should not be contacted for any other purpose. Thank you very much!
More about ITM
With us, you will have the opportunity to work in an international environment on ground-breaking projects that can have a significant impact on cancer care worldwide. We are looking for dedicated, talented and passionate professionals who share our vision and want to help shape the future of oncology. If this exciting challenge appeals to you and you would like to contribute to realising our common goal, please do not hesitate to send us your application. We look forward to hearing from you!
For more information please visit: www.itm-radiopharma.com