ARTO is partnered with an exciting, well-established infectious diseases focussed biotech located in Germany
We are helping them source a Medical Director, Clinical Development to join their team and oversee the design and execution of their early stage clinical trials.
The candidate will have the following responsibilities:
Oversee the design and execution of designated early stage clinical trials.
Building and leading development capabilities within the organization and for managing/building strong collaborative relationships with KOLs
Developing clinical study protocols and clinical development plans and obtaining cross-functional input to execute on clinical development strategies
Working in close collaboration with internal functions and designated CROs to ensure quality and timely execution of the clinical programs
Overseeing the assessment of clinical pharmacology, safety, and efficacy data
The candidate shall bring in the following expertise and qualifications:
Education: an advanced degree in a relevant discipline, with a strong preference for an M.D. qualification or equivalent
5-7+ years relevant experience in (early) clinical development within the pharmaceutical and/or (start-up) biotech environment, preferably working in infectious diseases related areas
Experience in ensuring proper clinical conduct of study protocols in compliance with GCP and local/global trial regulations, overseeing and providing clinical guidance to CRO medical monitors (and study investigators, as needed) and study teams, and leading the development of study protocols, protocol amendments, and clinical study reports
Excellent communication skills including written, oral, and presentation skills
Ability to work effectively in a dynamic and growing organization; assuming multiple roles and responsibilities and meeting stretch goals by setting priorities
A hands-on, pragmatic, non-hierarchical approach with an open, uncomplicated, committed, and motivated style
🌎 Hybrid role, applicants must be open to frequent travel and located within the European time zone.