Clinical Research Director (m/f) Early Development Diabetes : Frankfurt am Main, Germany
BE PART OF OUR AMBITION
At our site in Frankfurt/Main we are looking for a
Clinical Research Director (m/f) Early Development Diabetes
This role is key to supporting the global clinical development for new diabetes products at Sanofi, and includes decisions on how we best position drugs early in development to address unmet needs, and become competitive in the diabetes market in the future. The work includes working with the scientists to help planning for best development of promising new molecules, planning for and implementing a clinical plan, including studies through phase 2b. The CRD works within the clinical team and reports to the global project head for early development in diabetes. Within the team, the CRD supervises the conduct of clinical activities (studies, filing preparation etc) of the project.
- Supports the clinical development with regard to ongoing development activities
- Provides clinical input to the Target Product Profile
- Acts as an internal expert on the clinical research area related to the clinical project and will be sparring with internal and external experts to insert the best scientific input available
- Contributes to the clinical part of meeting requests and briefing packages for meetings with regulatory agencies
- Generates the extended synopsis of study protocol and reviews the protocols and protocol amendments prepared by the Clinical Study Director (CSD)
- Writes or updates the clinical section of the Clinical Investigator Brochure and the clinical parts of the Clinical Trial Authorization dossier (IMPD, IND) in collaboration with the pharmacovigilance (GPE) department and the clinical pharmacologist
- Reviews and when appropriate approves the committees charters, clinical study reports, statistical analysis plan etc.
- Contributes to the summary of clinical efficacy and clinical overview of the Common Technical Document (CTD)
- Provides input and reviews all clinical sections of the CTD (clinical pharmacology, summary of clinical safety) and other sections whenever appropriate
- Prepares answers to questions from regulatory Agencies on the clinical efficacy of the project and collaborates with GPE in preparing answers on the clinical safety of the project, collaborates on other sections whenever appropriate
- Works with external experts and through available publications to access all science relevant to the field of the project
Requirements and Qualifications
- Degree in Medicine
- Qualification / previous experience in endocrinology and/or diabetes and metabolism
- At least 3 to 5 years experience in clinical drug development or related departments
- Knowledge in ICH, GCP and local regulations in main regions/countries (US/EU/JAPAN)
- Fluent in English
- Publication and presentation skills documented
- Medical and scientific expertise in diabetes and metabolism
- Development experience in diabetes appreciated
- Management skills
- Some level of team leadership experience preferred
- Excellent intercultural communication (clinical representative for the project)
- Transversal leadership
- Experience in collaboration in clinical research
- An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
- An attractive, market-oriented salary aligned with your qualifications and including social benefits above average (e.g. company pension plans, health management).
- An individual and well-structured introduction and training of new employees.
- You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully.
- As a globally successful and constantly growing company, Sanofi provides international career paths as well.
If you are interested, please send us your online application.
Sanofi-Aventis Deutschland GmbH
HR Recruitment Services
Industriepark Höchst • Gebäude K 703
D-65926 Frankfurt am Main