ITM Isotope Technologies Munich SE
Head of Legal and Compliance, US (f/m/d)
ITM Isotope Technologies Munich SE, Princeton, New Jersey, us, 08543
Head of Legal and Compliance, US (f/m/d) Join to apply for the
Head of Legal and Compliance, US (f/m/d)
role at
ITM Isotope Technologies Munich SE Head of Legal and Compliance, US (f/m/d) 1 day ago Be among the first 25 applicants Join to apply for the
Head of Legal and Compliance, US (f/m/d)
role at
ITM Isotope Technologies Munich SE Get AI-powered advice on this job and more exclusive features. About ITM
Do you have the following skills, experience and drive to succeed in this role Find out below.
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). 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).
We would like to fill the following permanent vacancy in a hybrid working model as soon as possible
Your role
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
Your profile
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
Our offer
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.Seniority level
Seniority levelExecutive Employment type
Employment typeFull-time Job function
Job functionLegal IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at ITM Isotope Technologies Munich SE by 2x Get notified about new Head of Legal jobs in
Princeton, NJ . Princeton, NJ $211,440.00-$317,160.00 1 week ago Director, Contracts and Transactions Counsel Princeton, NJ $228,000.00-$307,000.00 20 hours ago New Jersey, United States $300,000.00-$350,000.00 2 weeks ago Director, Regulatory Affairs - Job ID: 1702 Princeton, NJ $225,000.00-$240,000.00 2 days ago East Brunswick, NJ $160,000.00-$200,000.00 4 weeks ago Plainsboro, NJ $200,000.00-$250,000.00 1 week ago Trenton, NJ $125,000.00-$250,003.00 1 month ago Senior Director, Regulatory Affairs - Job ID: 1668 Princeton, NJ $260,000.00-$275,000.00 18 hours ago New Jersey, United States $175,000.00-$250,000.00 1 week ago Associate Director of Regulatory Affairs Yardley, PA $150,000.00-$195,000.00 1 week ago Princeton, NJ $176,400.00-$327,600.00 1 week ago Burlington, NJ $150,000.00-$190,000.00 3 days ago Senior Director, Regulatory Affairs -Specialty Bridgewater, NJ $176,000.00-$243,000.00 2 weeks ago Executive Director, Regulatory Affairs Strategist Bridgewater, NJ $247,000.00-$345,467.00 2 days ago New Jersey, United States $225,000.00-$275,000.00 2 weeks ago Associate Director, Global Regulatory Affairs, Strategy Princeton, NJ $165,600.00-$248,400.00 2 weeks ago Bridgewater, NJ $165,000.00-$226,000.00 3 days ago Bridgewater, NJ $165,000.00-$226,000.00 3 hours ago VP, Regulatory Intelligence & ComplianceAssociate Director Regulatory Affairs CMC Princeton, NJ $160,000.00-$199,600.00 1 week ago Executive Director, Regulatory Affairs StrategistAssociate Director, Regulatory Affairs Advertising & Promotion Compliance Princeton, NJ $170,000.00-$190,000.00 2 days ago New Jersey, United States $229,200.00-$310,000.00 19 hours ago New Jersey, United States $390,000.00-$455,000.00 1 month ago Princeton, NJ $225,000.00-$337,500.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
Head of Legal and Compliance, US (f/m/d)
role at
ITM Isotope Technologies Munich SE Head of Legal and Compliance, US (f/m/d) 1 day ago Be among the first 25 applicants Join to apply for the
Head of Legal and Compliance, US (f/m/d)
role at
ITM Isotope Technologies Munich SE Get AI-powered advice on this job and more exclusive features. About ITM
Do you have the following skills, experience and drive to succeed in this role Find out below.
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). 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).
We would like to fill the following permanent vacancy in a hybrid working model as soon as possible
Your role
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
Your profile
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
Our offer
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.Seniority level
Seniority levelExecutive Employment type
Employment typeFull-time Job function
Job functionLegal IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at ITM Isotope Technologies Munich SE by 2x Get notified about new Head of Legal jobs in
Princeton, NJ . Princeton, NJ $211,440.00-$317,160.00 1 week ago Director, Contracts and Transactions Counsel Princeton, NJ $228,000.00-$307,000.00 20 hours ago New Jersey, United States $300,000.00-$350,000.00 2 weeks ago Director, Regulatory Affairs - Job ID: 1702 Princeton, NJ $225,000.00-$240,000.00 2 days ago East Brunswick, NJ $160,000.00-$200,000.00 4 weeks ago Plainsboro, NJ $200,000.00-$250,000.00 1 week ago Trenton, NJ $125,000.00-$250,003.00 1 month ago Senior Director, Regulatory Affairs - Job ID: 1668 Princeton, NJ $260,000.00-$275,000.00 18 hours ago New Jersey, United States $175,000.00-$250,000.00 1 week ago Associate Director of Regulatory Affairs Yardley, PA $150,000.00-$195,000.00 1 week ago Princeton, NJ $176,400.00-$327,600.00 1 week ago Burlington, NJ $150,000.00-$190,000.00 3 days ago Senior Director, Regulatory Affairs -Specialty Bridgewater, NJ $176,000.00-$243,000.00 2 weeks ago Executive Director, Regulatory Affairs Strategist Bridgewater, NJ $247,000.00-$345,467.00 2 days ago New Jersey, United States $225,000.00-$275,000.00 2 weeks ago Associate Director, Global Regulatory Affairs, Strategy Princeton, NJ $165,600.00-$248,400.00 2 weeks ago Bridgewater, NJ $165,000.00-$226,000.00 3 days ago Bridgewater, NJ $165,000.00-$226,000.00 3 hours ago VP, Regulatory Intelligence & ComplianceAssociate Director Regulatory Affairs CMC Princeton, NJ $160,000.00-$199,600.00 1 week ago Executive Director, Regulatory Affairs StrategistAssociate Director, Regulatory Affairs Advertising & Promotion Compliance Princeton, NJ $170,000.00-$190,000.00 2 days ago New Jersey, United States $229,200.00-$310,000.00 19 hours ago New Jersey, United States $390,000.00-$455,000.00 1 month ago Princeton, NJ $225,000.00-$337,500.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr