Early Clinical Development Lead

vor 3 Wochen

Munich, Deutschland ITM Isotope Technologies Munich SE Vollzeit

**Your Role**:

- Member of the medical team, with key role leading the translation of therapeutic radiopharmaceuticals from the late preclinical stage of drug discovery to the design and execution of early clinical development (Phase I and Phase II)
- Develop and lead the early clinical development plans for the assigned drugs
- Lead the design of Phase I/II clinical study protocols, the execution of the clinical trials and the writing of 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 and support to late stage clinical studies
- Ensure integrity of data and interpretation of clinical study results
- Lead the early development and clinical pharmacology interactions with regulatory authorities (e.g. Investigator Brochures, regulatory dossiers, scientific advice meetings, answering List of Questions)

**What we are looking for**:

- Doctor of medicine, preferably with clinical experience in oncology
- Solid experience in managing early clinical development and translational medicine of new chemical entities (clinical pharmacology, PK/PD, dose finding Phase I/II clinical studies); 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, BOIN 1/2 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
- 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 environment

**What we offer**:

- 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

At ITM, we work together towards one common goal - the benefit of our patients. This is what drives us, every day. This is what we are passionate about. For this we create opportunities that are as unique as our team. We encourage diversity and inclusion - the input of our multi-cultural employees makes us who we are.

Only together we can contribute to significantly improving the outcome and quality of life of cancer patients worldwide and to giving better answers than “maybe”.

Does this sound like you? Are you interested in shaping the future of ITM and joining one of our highly committed teams in an innovative work environment?

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