Manager Preclinical Development (M/F)

Promethera Biosciences is a global innovator in liver therapeutics whose mission is to enable patients to overcome acute and chronic liver diseases. Our lead clinical program, derived from our patented cell technology platform HepaStem, is designed to benefit from its immune-modulatory and anti-fibrotic properties. In addition to our cell-based pipeline we develop antibody technologies, such as the anti-TNF-R1 antibody Atrosimab, to complement and diversify our therapeutic options. We are a team of international experts operating out of facilities in Mont-Saint-Guibert, Belgium, Durham, NC, USA, Tokyo, Japan and Basel, Switzerland.

If you are sharing our vision of becoming the world leader in regenerative medicine in the liver space by developing innovative advanced therapies for acquired liver diseases and if you are looking for new challenges amongst a dynamic and international team of more than 100 people, consider a collaboration with our fast-growing company. Promethera Biosciences is currently hiring a “Manager Preclinical Development”.

The Manager of Preclinical Development will report to the VP Product Development. S/he will be responsible for running preclinical development across multiple programs.

MAIN RESPONSIBILITIES

• Oversee the design and management of pre-clinical studies (GLP and non-GLP) for inclusion in regulatory documents, including PoC, pharmacology, toxicology, and biodistribution studies
• Manage contract research organizations (CROs) and external collaborations to support pre-clinical development programs
• Work closely with other functional areas and colleagues to ensure that all pre-clinical studies are performed in a quality, timely and scientific manner
• Write and edit preclinical study plans and reports
• Oversee drafting of preclinical sections for IB/IMPD
• Ensure compliance with global pre-clinical studies regulatory guidelines

QUALIFICATIONS / REQUIREMENTS 

• Ph.D. in biological sciences
• FELASA C accreditation
• Strong knowledge of biologics pre-clinical drug development and EMA/FDA/PMDA requirements (toxicology, biodistribution) is essential
• Minimum 3+ years' experience in biotech/industry setting
• Excellent written and oral communication skills
• Fluency in English & French, all other language is an added value
• Experience managing direct reports, CROs, and external collaborations
• Demonstrable expertise relating to all aspects of the drug development process and the ability to identify and resolve complex methodological issues relating to programs
• Ability to make effective and compelling presentations in both large and small groups is required
• Experience with Cell Therapy drug development is preferred
• Ability to demonstrate flexibility and navigate in a fast-paced and dynamic biotech environment

LOCATION

• At our headquarters in Mont-Saint-Guibert, Belgium