Director, Toxicologist
- Employer
- Genmab
- Location
- Princeton, New Jersey (US)
- Salary
- Annual Salary / Bonus / LTI /Comprehensive Benefits
- Closing date
- Jun 30, 2019
View more
- Position
- Medical Director
- Category
- Translational Research
- Hours
- Full Time
- Education
- PHD
- Career Fair Category
- Career Fair
Job Details
About Us
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.
The Role
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.
Key Accountabilities
- 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.
Other
if you are interested in the position, please apply via https://genmab.loop.jobs/job/Genmab-Princeton-NJ-New-Jersey/72020596
Company
Be part of the extra[not]ordinary™
Are you caring, candid, impact-driven and determined to make a difference? Join our unstoppable team as we improve the lives of patients through innovative and differentiated antibody therapeutics.
About Genmab
Founded in 1999 in Copenhagen, Denmark, Genmab is an innovative biotech company that has become a leader in antibody biology and innovation. Our product pipeline and next-generation antibody technologies are the result of our strong company culture, a deep passion for innovation, and desire to transform cancer treatment and serious diseases.
When you work with us, you’ll be part of a warm, fun, dynamic community, and team up with some of the best, most authentic individuals in locations around the world, who care deeply and share in a relentless drive to innovate and create transformational medicines. People who are candid, impact-driven, and a little unconventional; who seek out and embrace the opportunity to build new and bold futures within a rapidly growing and innovative biotech company; who bring their full selves to work and show up for each other - rolling up their sleeves to get the job done. This translates into a place where you can be authentically you; are empowered to innovate, build solutions, and execute; feel cared for and supported in growth; and are a critical part of changing the lives of patients around the world through transformative cancer treatment.
- Website
- https://www.genmab.com/
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