Director, Oncology Clinical Development Lead - Munich, Deutschland - ITM Isotope Technologies Munich SE

ITM Isotope Technologies Munich SE

Geprüftes Unternehmen

Munich, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Your Role:

Member of the medical team, with key role of providing clinical oncology strategy to the entire development pipeline and acting as a clinical development lead for assigned compounds during phase 1
Develop and lead the clinical development plans for the assigned compounds, provide oncology expertise and strategic contribution to the entire pipeline
Interact closely with other (core team) functions e.g. preclinical development, medical affairs, regulatory affairs, pharmacovigilance, clinical operations in developing compounds through the different clinical development phases and phase transitions
Lead the design of 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 molecular entity 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
Ensure integrity of data and interpretation of clinical study results
Lead the development and medicoscientific interactions with regulatory authorities for assigned development projects (e.g. Investigator Brochures, regulatory dossiers, scientific advice meetings, answering List of Questions)

What we are looking for:

Doctor of medicine, preferably with a board accreditation in oncology
Solid experience (track record of > 5 years in the industry) in oncology clinical development of new chemical entities (early and late clinical stage development, development of the clinical strategy, setting up a clinical development plan and target product profiles in collaboration with other functions), experience in radiotheranostic development would be a distinct advantage
Solid background in the development of clinical study protocols and study reports including sound knowledge of clinical development methodology and study designs
Strategic mindset, with previous experience in 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 team spirit and leadership experience, with ability to work in a mediumsize 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
Flexible home office possibilities

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?

Then send us your detailed CV including earliest start date and salary expectations. The position is intended for the ITM Oncologics GmbH, a company of the ITM group. Applications are accepted either in German or English language.