Job Description
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 in Garching as soon as possible
Preclinical Study Manager (f/m/d)
- Support of R&D in preclinical development of PoC studies and early stage development
- Responsibility for the development of preclinical study programs (GLP, non-GLP Pharmacology and Toxicology), to support clinical programs and Marketing Authorization for radiopharmaceutical drugs and radiodiagnostica
- Alignment with program leaders, R&D, Clinical Development and Regulatory Affairs
- Build and manage a strong relationship to CROs and ensure that the study quality fulfills all preclinical guidelines for translation to clinical phases and drug approval
- Ensure appropriate CROs study proposals, quotes and oversight of study conduction, timelines and its execution
- Set up, negotiation and maintenance of Quality Agreements
- Identification and mitigation of quality and compliance issues and promotion of lessons-learned
- Master of Science degree, ideally PhD in natural science, veterinary sciences or adequate education
- Sound knowledge and extensive experience throughout all stages of preclinical development, planning and execution of preclinical studies
- Knowledge in GLP regulations and in FDA / EMA guidelines for preclinical development
- Proven experience in providing high quality input and guidance to program and study teams
- Project management experience and ability to lead complex projects in a highly matrixed and highly outsourced model
- Strong problem solving skills, stakeholder management and excellent communication skills
- Basic statistical knowledge and the ability to interpret data and understand the underlying relationships and information would be an advantage
- Fluency in written and spoken business English, knowledge of German is an advantage
- 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)