Description:
Job Title: Manager Preclinical Development

Full-time. Location: Walloon Brabant

TalentSource Life Sciences is the division of CROMSOURCE dedicated to flexible staffing solutions. Our client is a specialist in the development of cell-based therapies. In this role, you will report to the Vice President and 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 document, pharmacology, toxicology, and biodistribution studies
• Manage contract research organisations (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 Investigational Medicinal Product Dossier (IMPD)
• Ensure compliance with global pre-clinical studies regulatory guidelines

Qualifications / Requirements

• Ph.D. in biological sciences
• 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

The Benefits of Working for TalentSource in Belgium

• Competitive Salary
• Group and hospitalisation insurance
• Electronic meal vouchers
• Internet reimbursement
• Dedicated Line Manager
• Regular face-to-face or phone meetings with line manager
• Full annual performance review process
• Ad-hoc team events and end of year party
• Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
• Employee satisfaction survey - your feedback is important for continuous improvement

If you have the experience needed for this position, please apply directly to https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00001821

If you would like to discuss the role before applying through the website, please contact Careers@cromsource.com

for more information.

Why choose TalentSource Life Sciences/CROMSOURCE?

TalentSource Life Sciences is a fully dedicated flexible resourcing department at CROMSOURCE, a family owned international, full-service Contract Research Organisation. CROMSOURCE comes from the merger of MSOURCE and CROM and we have been supporting clients with outstanding clinical research and resourcing services since 1994. Successful growth has been achieved by putting high quality and client focus at the heart of everything we do and we are proud to partner with industry leading Pharmaceutical, Biotechnology, Medical Device and Marketing Communications worldwide.

Our employees are the most valuable company asset and because we want to retain our staff, we ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our current below industry average turnover rates.

Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are experts providing experts - highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world.

Keywords: Management, Manager, Preclinical, Pre-clinical, GLP, CRO, Contract Research Organisation

Skills: Preclinical, Clinical Manager, GLP, CRO Location: Belgium