The Life Science Career Network

CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes. 

Our client develops innovative therapeutic antibodies in immuno-oncology fighting cancer cells by reactivating the body's own defense mechanisms. 

For the next possible date we are looking for a Head of Toxicology to step in a permanent position.

Head of Toxicology (m/w/d)

Responsibilities:

  • Lead toxicology unit within the company’s Preclinical Development department reporting to the VP Preclinical Development
  • Drive development and implementation of project plans regarding non-clinical safety for all preclinical and clinical development programs
  • Organize and monitor toxicological studies in collaboration with Contract Research Organizations (CROs)
  • Work in close contact with bio-analytical unit to ensure timely availability of adequate methods to support animal studies
  • Perform data analysis, review and compile study reports for internal decision making and reflect results in regulatory documents (e.g. IND, IB and BLA/MAA)
  • Instruct and mentor team members in non-clinical safety aspects
  • Act as toxicology expert in cross-functional global program teams as required

Qualifications & Experience

  • Degree in Life Sciences (PhD/MD/VMD) with at least 5 years industrial experience in the described fields, preferably 3+ years industry experience in development of biologics, Qualification as board certified toxicologist (e.g. DGPT, ERT, DABT) is a plus
  • Demonstrated knowledge of biologics drug development and immunotherapy or oncology
  • In-depth knowledge in the areas of Toxicology, Pharmacokinetics, and Immunogenicity incl. recent and upcoming development of regulatory guidelines
  • Track record of excellence in the area of CRO liaison incl. experience in managing animal studies according to GLP
  • Experience in regulatory agency interactions, e.g. Pre-INDs, INDs or market authorizations
  • Ability to conduct multiple projects delivering agreed milestones adhering to timelines and budget
  • Ability to work in interdisciplinary development teams incl. excellent communication skills and fluency in English (oral and written)

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.