Manager Preclinical Development

Manager Preclinical Development

CROMSOURCE

Walloon Brabant, Belgium

TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Manager Preclinical Development for the Walloon Brabant to strengthen the team of one of our TOP Biopharma clients.

The Manager of Preclinical Development will report to the Vice President Product Development 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.

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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