Associate Director, Non-Clinical Safety & Toxicology
Genmab
Japan
Posted on Feb 6, 2025
ジェンマブは、革新的で独自性のある抗体治療薬の開発に注力し、患者さんの人生をより豊かにすることを目的としています。
The Nonclinical Safety & Toxicology Team are looking for an experienced toxicologist fluent in both English and Japanese who will be based in Japan for a newly created position as sponsor monitor for nonclinical safety studies with Genmab’s pharmaceutical drug candidates outsourced to our CRO laboratory partners in Japan.
The Nonclinical Safety Team at Genmab is responsible for the nonclinical safety evaluation of our innovative therapeutic antibodies. At the intersection of pharmacology, immunology, toxicology, medical and regulatory sciences, and with a strong dedication to laboratory animal welfare, Nonclinical Safety & Toxicology supports the safety of patients in clinical trials with our new drug candidates or being treated with our marketed medicines. In this position, you will work in close collaboration with the project toxicologists and the CRO study coordinator in our Nonclinical Safety department, located in New Jersey, USA and Copenhagen, Denmark, as well as with scientists in other departments (for example: in bioanalysis, pharmacokinetics, pharmacology, translational research, pathology, CMC, and QA), to set up and oversee regulatory nonclinical safety studies performed at CROs in Japan. You will support the Nonclinical Safety Leads with conduct of the studies, translation, issue resolution, and the regulatory nonclinical safety evaluation of Genmab’s antibody-based drug candidates prior to the clinical trials.
Your tasks will include:
Work in close collaboration with the Genmab Nonclinical Safety Lead/Project toxicologist, other scientists, QA, and the CRO Study Director to generate GLP and non-GLP Study Plans for in vivo and in vitro nonclinical safety studies, to support Phase 1 and later stage clinical trials and marketing of Genmab’s pharmaceutical drug candidates.
Ensure that the study designs and setup are scientifically rigorous, and i accordance with applicable regulatory and quality guidelines (ICH, regional, national, Good Laboratory Practice, Genmab Animal Welfare Policy, and Nonclinical Safety standards)
Coordinate safe and timely delivery/shipment of test articles/study samples with appropriate safety quality, and regulatory/legal documentation between Genmab and CRO partners
During the conduct of the studies at CROs, be the primary Genmab sponsor contact for the CRO Study Directors
Coordinate collaboration between the CRO Study Director and Genmab-based Principal Investigators (bioanalysis, pharmacokinetics, etc.)
Conduct on-site sponsor monitor visits at the CROs during in-life phases of every study
On an ongoing basis monitor and evaluate observations and data from ongoing studies and communicate essential information to the project toxicologist and project team
On behalf of Genmab, facilitate and conduct Genmab scientific review of principal investigator and study reports before finalization
Your qualifications:
You have a BS or MS degree in biological sciences (toxicology, pharmacology, veterinary, pathology, human biology, immunology or similar)
You have practical experience with the scientific and regulatory development process for new pharmaceutical drug candidates, in particular with nonclinical development of biopharmaceuticals
You have at least 5-10 years’ experience as a study monitor and/or study director conducting non-GLP and GLP toxicology studies, e.g. as Study Director at a CRO or in a pharma company
You are familiar with the regulatory, legal and ethical issues relating to the use of laboratory animals
You are able to travel regularly within Japan for site visits of ongoing studies
You are proficient in Japanese and English written and spoken language,
You are highly efficient with the organizational tools and skills needed to lead complex projects
You are able to work with an international and diverse team to accomplish organizational goals
You can analyze and present the results from complex, large datasets from toxicology studies
Must have schedule flexibility to allow communication/meetings with US and EU-based Team members.
私たちは、社員ひとり一人が共通の目的に向かって、高い志を持ち、お互いを尊重し、共通の価値観をもとに日々仕事をしています。私たちの価値観の一つである誠実さを胸に、革新的な抗体治療薬の創薬に一人ひとりが主体性をもち取り組んでいます。ジェンマブでは、がん患者さんの人生をより豊かにすることを目的に、部門や国境を超え、世界中の深い専門知識を有した仲間たちと共にがん治療の将来に変革をもたらすこれまでにない経験をしていただけると信じています。
互いを尊重して協力し合うチームワークは、ジェンマブの重要な企業文化であり、そのため世界中の社員が、インクルーシブ、オープン、協力しあう姿勢を大切に日々仕事をしています。地域、教育、文化、国籍、年齢、性別などを超えた多様性を推進し続けていくことが、企業が継続して成長していくために重要であると考えています。そのため採用においても、性別、年齢等に関わらず、スキルや能力をもとに多様性を重視し進めています。
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