Non Clinical Safty Toxicology Associate Director

職種

• その他医薬品薬事/法規対応

• 前臨床研究

• 医薬品薬事/法規対応

仕事内容

• 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

求める能力・経験

• 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

語学

英語でビジネス会話が可能

雇用形態

給与

1,500万円〜2,000万円

勤務時間

休日・休暇

社会保険

備考

配属先

転勤

住所

東京都港区

制度

その他

制度備考