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 remote-based or hybrid working model in Garching as soon as possible
Director Clinical Operations (f/m/d)
Your role
- Clinical Trial Oversight & Strategy: Lead and oversee assigned clinical trials, ensuring timely execution within budget and regulatory compliance. Develop clinical trial management strategies, including budget, resourcing, and scenario planning, aligned with the Clinical Development plan. Monitor trial progress, mitigate risks, and implement corrective actions as needed
- Leadership & Team Management: Mentor and guide Clinical Trial Managers (CTMs) and Senior CTMs, providing coaching, performance feedback, and career development. Oversee resource allocation to ensure optimal staffing and alignment with study needs. Facilitate communication across teams to ensure alignment on project goals and timelines
- Vendor & Budget Oversight: Manage vendor activities (CROs, eCRFs, eTMF, software), ensuring adherence to trial timelines and deliverables. Oversee Work Orders (WOs) and Change Orders in alignment with Master Service Agreements (MSAs), monitor vendor performance, and ensure timely invoice ratification and payments. Review and approve budgets, resource plans, and timelines
- Process Improvement & Compliance: Develop and optimize SOPs, workflows, and tools to enhance efficiency and ensure regulatory compliance. Drive continuous improvement initiatives and standardization across clinical operations. Ensure effective use of clinical trial systems (CTMS, eTMF) and collaborate with IT for system optimization
- Cross-Functional Collaboration & Reporting: Coordinate with regulatory, data management, and other teams to align on study milestones. Provide updates on trial status, budget, risks, and key accomplishments to leadership. Lead initiatives to enhance collaboration across functions, ensuring operational excellence and strategic alignment
- Additional Responsibilities: Oversee training and development of new team members, ensuring smooth onboarding and ongoing learning. Identify process gaps and propose improvements to enhance trial execution. Perform additional tasks as needed to support successful study completion and adherence to Good Clinical Practice (GCP)
Your profile
- Graduation from a recognized institution (preferably in Life Sciences, Pharmacy, Chemistry, or Biology) with a focus on clinical research or related fields
- Several years of professional experience in clinical operations, with significant exposure to managing assigned clinical trials. Experience in oncology studies is highly desirable
- Proven experience leading and mentoring Clinical Trial Managers (CTMs) and senior clinical operations teams. Strong interpersonal skills and the ability to manage cross-functional teams effectively
- In-depth understanding of assigned clinical trial processes, from protocol development to trial completion. Expertise in clinical trial design, risk management, and vendor oversight
- Comprehensive knowledge of FDA, EMA, ICH/GCP regulations and guidelines. Familiarity with global regulatory requirements for clinical trials
- Experience in using clinical trial management systems (CTMS, eTMF) and implementing SOPs and templates to standardize and optimize trial processes
- Strong ability to analyse trial data, identify risks, and implement corrective actions to ensure trials stay on track
- Excellent written and verbal communication skills in English (additional languages are a plus). Ability to clearly articulate trial progress, challenges, and strategies to senior leadership
- Strong problem-solving skills with a proactive, goal-oriented approach to addressing challenges. Ability to make decisions under pressure while maintaining trial integrity
- Oncology Experience: Solid background in oncology, with a deep understanding of current therapies and emerging trends in the field. Interest in innovative therapies and clinical trial designs is a plus
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
- Job bike or subsidised job ticket
- Above-average contribution to the company pension scheme
- Individually tailored further training programme (including German and English courses)
- Health promotion programmes (e.g. EGYM Wellpass, subsidy for local fitness studio, sponsorship of sporting events, various lifestyle coaching sessions)
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.
Contact
Nadine Sürken
+49 89 329 8986 -1709
career@itm-radiopharma.com
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
