Head of Legal and Compliance

About this job

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).

We would like to fill the following permanent vacancy in a hybrid working model as soon as possible

Head of Legal and Compliance, US (f/m/d)

Serve as the primary legal advisor for ITM USA across commercial, medical, market access, HR, and corporate matters

Draft, review, and negotiate a wide range of contracts, including vendor agreements, clinical trial agreements, licensing arrangements, NDAs, and service contracts

Advise on U.S. FDA regulations, promotional review, labeling, and advertising for radiopharmaceutical products

Partner with ITM SE’s corporate counsel and legal team to align on global corporate governance and strategies

Support transactional activity, including business development, partnerships, and strategic alliances

Develop and implement the U.S. compliance program, including policies, SOPs, training, and monitoring aligned with OIG, DOJ, and PhRMA guidelines

Oversee compliance with laws and regulations including Anti-Kickback Statute, False Claims Act, Sunshine Act, HIPAA, and state‑specific requirements

Serve as Compliance Officer for the U.S., conducting risk assessments and leading investigations of potential violations or breaches

Chair or participate in relevant compliance committees and advise on review of promotional and medical materials (e.g., MLR process)

Lead compliance training programs for field and HQ personnel

Monitor legal and regulatory developments that impact ITM’s U.S. operations

Collaborate with external counsel, consultants, and industry groups to ensure proactive risk mitigation

• J.D. from an accredited U.S. law school; licensed to practice in at least one U.S. jurisdiction.

• Minimum 10 years of relevant legal and compliance experience in the biopharmaceutical industry, including at least 3 years in a leadership role

• Expertise in U.S. healthcare laws, FDA promotional regulations, and compliance frameworks (e.g., OIG Guidance, PhRMA Code)

• Experience supporting commercial product launches, ideally in oncology or radiopharmaceuticals

• Strong business acumen and ability to provide pragmatic, risk‑balanced legal guidance

• Demonstrated ability to work cross‑functionally and influence at all levels of the organization

• Exciting challenges in an up‑and‑coming and fast‑growing company with a high degree of creative freedom

• An open working atmosphere in an international corporate culture with short communication channels

• Comprehensive onboarding programme

• Flexible working hours with home office options

• Attractive special payments

• Just a good salary? Not with us! We also offer you

• Employee participation programme

• Individually tailored further training programme (including German and English courses)

Do you have these qualifications, are you willing to develop yourself further and are you looking forward to becoming a key part of our future? Great! We should get to know each other!

When you apply, please let us know your earliest possible starting date and your salary expectations. You can submit your CV in German and English in docx or pdf format.

Nadine Sürken

49  
-1709

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!

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!

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