Associate Director, Toxicologist
Genmab is an international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.
Genmab is currently looking for an Associate Director, Toxicologist located in either Princeton, NJ or Utrecht, NL. This position will require up to 30% travel.
In this position, you are part of the international non-clinical safety team and you report to the Head of the Non-Clinical Safety team. As a key member of international, multidisciplinary project teams, you provide non-clinical safety advice and you ensure the execution of Genmab’s non-clinical safety strategy.
- You lead safety assessments of potential new medicines and maintain effective interactions with international teams in research, pre-clinical development, PK/PD modeling, clinical operations, manufacturing, medical and regulatory affairs.
- Prepare non-clinical safety plans that support clinical trials and marketing applications.
- Be a key player in the writing of regulatory documents including non-clinical sections in IND’s, CTA’s and BLA’s.
- In addition, you contract, monitor, review and sign-off on non-GLP and GLP safety studies conducted at various contract laboratories. Must be flexible and open to change.
Skills & Experience
- You possess a background as DVM, PhD in toxicology or equivalent and at least five to ten years of experience as a project toxicologist in non-clinical safety studies for biologicals and/or pharmaceuticals.
- Successful track-record of managing toxicology projects and working in multiple cross-functional and international teams.
- Capable of directing research at CRO’s and are able to take decisive actions.
- Solid experience with regulatory processes and guidelines as well as with Good Laboratory Practice and other quality systems for the pharmaceutical drug development process.
- You have a positive, open and objective mind-set but you also have critical thinking skills and are assertive. You speak and write English fluently.
- The successful candidate will possess depth of expertise to develop a broad nonclinical toxicology program for assigned projects and will have excellent organizational and communication skills required for highly collaborative global partnerships.
if you are interested in the position, please apply via https://genmab.loop.jobs/job/Genmab-Princeton-NJ-or-Utrecht-NL-New-Jersey/71522582