Unicyte - Head of Translational Development (m/f/d)
Req#: 336df673-de73-597b-aabf-4c2f62775c3e
Your assignments
* Design and conduct non-clinical development studies (GLP and non-GLP) covering pharmacology, safety, toxicology and ADME
* Implement streamlined approaches to clinical target validation (e.g. target distribution, Mechanisms of Action), preclinical proof of concept, and BLA or NDA-enabling studies such as definitive MoA/pharmacology studies
* Support projects by supervising Translational Strategist serving cell therapy project teams
* Build and progress the early cell therapy portfolio including designing the programs
* Develop and apply in-depth knowledge of cell therapy, emerging meaningful preclinical and clinical research, product and competitive landscapes including current treatment strategies, current and potential competitors, and new therapeutic developments
* Build and maintain positive relationships with opinion leaders, collaborators, scientific advisors, alliance partners and patient advocacy groups to help drive the scientific communications program
* Represent early development functions at the Executive and Board levels
* Ensure the integration of expertise/findings from discovery research, nonclinical and clinical groups while facilitating broader discussion with groups such as medical indication specialists, regulatory, process development, clinical operations, compliance and legal
Your profile
* PhD and/or MD with a track record in ATMP and Cell therapy translation science and proven experience in developing cellular therapies
* At least 15 years’ experience in a pharmaceutical/biotech company, CRO, or academic medical center, or related experience
* Strong knowledge of disease area biology, pharmacology, toxicology, ADME, translational science and clinical trial design
* Strong communication and influencing skills (fluency in English, German and or Italian would be a plus)
* Highly developed problem solving and risk management skills
* Highly developed collaborative working skills on clinical trials
* Ability to act as an external ambassador and to influence external organisations to improve the image and reputation of Unicyte and Fresenius Medical Care
About the company
Fresenius is a globally active health care group providing products and services for dialysis, hospitals and the medical care of patients at home. In addition, Fresenius focuses on clinic operations as well as on engineering and services for hospitals and other health care facilities.
#J-18808-Ljbffr