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 vacancy as soon as possible:

Early Clinical Development Lead (f/m/d)

• Member of the medical team, with key role leading the translation of compounds from the late preclinical stage of drug discovery to the design and execution of early clinical development plans
• Develop and lead the early clinical development team
• Interact closely with preclinical development in translating compounds through the lead identification and candidate validation stage gates
• Develop translational medicine / Phase I strategy for candidate compounds
• Lead the design of Phase I/II clinical study protocols and clinical study reports, according to current international regulations and guidelines
• Support strategic development of the company with the identification and assessment of new early opportunities, with participation in due diligence activities
• Lead the organization and running of national and/or international expert consultations and multidisciplinary advisory boards
• Contribute to the publications related to clinical data and presentation of results at internal and external meetings
• As a member of the medical team providing clinical pharmacology input to late stage clinical studies
• Ensure integrity of data and interpretation of clinical study results
• Monitor safety of compounds in clinical development, with participation in safety monitoring boards
• Lead the clinical pharmacology interactions with regulatory authorities (e. g. Investigator Brochures, regulatory dossiers, scientific advice meetings, answering List of Questions)

• Doctor of medicine or radiopharmacist, preferably with clinical experience in nuclear medicine
• Solid experience in managing early clinical development of new chemical entities (clinical pharmacology, PK / PD, dosimetry, dose finding, Phase 1/2 clinical studies) and translational medicine; experience in radiotheranostic development would be a distinct advantage
• Solid background in the development of Phase I/II clinical study protocols and study reports including sound knowledge of early development methodology and design (basket studies, adaptive designs, etc.)
• Strategic mindset, with previous experience in early due diligence activities
• Sound knowledge of ICH-GCP and other relevant regulations/guidelines
• Experience in interacting with regulatory authorities
• Experience in drug safety and working with pharmacovigilance
• Demonstrated expertise in ability to lead complex medical and scientific discussions and synthesize and communicate information clearly
• Demonstrated leadership experience, with ability to work in a medium-size company with a matrix non-hierarchical environment

• A modern workplace and exciting opportunities in an evolving and fast growing company
• Challenging and varied projects in interdisciplinary, multicultural and highly professional teams
• A collegial corporate culture and short communication channels
• Flexible working hours with an attractive salary package and diverse corporate benefits

ITM Isotopen Technologien München AG
Human Resources
Walther-von-Dyck-Str. 4
85748 Garching, Germany
E-Mail: career@itm.ag