The Corporate Counsel, Clinical Development will provide legal services and support, primarily to Mitsubishi Tanabe Pharma Development America, Inc. (MTDA), Mitsubishi Tanabe Pharma Holdings America, Inc. (MTHA) and their affiliated companies. This is a dynamic role giving advice on legal and compliance issues as they arise from the clinical, safety, regulatory, medical, sourcing and executive teams of MTDA, and the business development, and research collaboration teams of MTHA.
Incumbent will be involved in all aspects of the development business and operate as part of cross-functional teams focused on developing pipeline products in the U.S. and acquiring or licensing products in the U.S. The attorney will be responsible for evaluating strategic and tactical research and development and business development plans, and advising clients on a broad array of issues relating to FDA pharmaceutical regulations, GxP requirements, product development, product labeling, non-promotional review, media materials, anti-trust, anti-kickback, competitor issues, compliance issues, regulatory policy, medical, industry and group company issues. The Corporate Counsel, Clinical Development will also be responsible for overseeing all contracts for MTDA and MTHA, including CRO agreements, clinical trial agreements, informed consent forms, consulting agreements, service agreements, supply agreements, and confidentiality agreements for MTDA, and development and license agreements, research collaboration agreements, terms sheets, consulting agreements, service agreements, and confidentiality agreements for MTHA.