We are looking to hire a
Senior Director Clinical Operations (f/m/d)
in a permanent, full-time position, reporting directly to the Chief Medical Officer.
Location: Ladenburg near Heidelberg or home based with regular visits to Ladenburg.
As Vice President Medical you will overall be responsible for providing medical, scientific, and strategic leadership for the successful planning, execution, and reporting of the medical aspects of clinical trials run by Heidelberg Pharma:
- You create the Clinical Development Plan, including FiH and PoC strategies, for clinical stage drugs.
- You prepare high quality study concept sheets, study protocols and study reports, Investigator Brochures, submission/registration documents, publications, etc. Also, you provide medical/ scientific input and drive the creation of further relevant clinical documents.
- You provide medical expertise for the clinical operations team. Furthermore, you are an active team member of cross-functional project teams. You also contribute to vendor selection and oversight (CROs, central laboratory, central imaging).
- In addition, you provide medical/ scientific input into e.g. business plan, project strategy, in-/out-licensing activities, etc. as assigned. You are the scientific and medical expert in clinical development with a strong interface to non-clinical drug development. You manage Key Opinion Leader interactions.
- Furthermore, you liaison investigators, Institutional Ethics Committees/ Institutional Review Boards, consultants and academic institutions within the area of responsibility and you prepare and participate in meetings with national supervisory authorities (e.g. EMA, FDA, BfArM).
- You ensure adequate safety overview and medical monitoring of the trials including periodic safety updates and organize and support DMCs as well as you assure compliance with ICH-GCP and other regulatory requirements.
- Further you create and approve internal and external training materials and processes.