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.
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.
- The primary focus of the position is to provide nonclinical safety support for mid and late stage projects 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 sections that support clinical trials and marketing applications.
- You will be a key player in the writing of regulatory documents including non-clinical sections with focus on investigator brochures, briefing documents, BLA’s/NDA’s, and other regulatory documents.
- Must be flexible and open to change.
Skills & Experience
- Possess a background as DVM, PhD in toxicology or equivalent and at least ten years of experience as a project toxicologist in non-clinical safety studies for biologicals and/or pharmaceuticals.
- Passionate and persistent with a track-record of successfully managed toxicology projects from discovery to mid/late stage development, and work in multiple cross-functional and international teams.
- 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 and knowledge of GLP regulations, ICH, and other regulatory guidance documents, and will have experience in writing nonclinical sections of regulatory documents, including BLA’s/NDA’s.
if you are interested in the position, please apply via https://genmab.loop.jobs/job/Genmab-Princeton-NJ-New-Jersey/72020596