Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America, we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.
Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.
The Senior Director, Clinical Development will fill a vital role in our growing organization serving as the Early Development Team Leader (EDTL) responsible for overseeing a globally based, multidisciplinary team responsible for successful delivery of development milestones including IND, FIH, POC, EOP2 and NDA. In addition to leading the Early Development Team (EDT), the individual will be responsible for supporting the development and writing of regulatory documents (IB/IND/CTA), study protocols and clinical development plans. The role will include oversight of design and conduct of FIH and proof of concept studies for new molecules that were discovered in Mitsubishi Tanabe Pharma Corporation (MTPC) laboratories or obtained through in-license activities. Presently, the role will be responsible for leading one or more projects with global teams including representatives from non-clinical, clinical operations, CMC, project management and regulatory affairs in preclinical to Phase IIa (human proof of concept). Therapeutic areas may vary and the pipeline candidates may be small molecules or biologics covering broad disease markets all the way down to narrow indications including orphan conditions.
With respect to leadership of the EDT, the responsibilities will vary based on the products’ life cycles, but will include the following:
Additional responsibilities outside the EDT include the following:
Preferred: Experience filing NDA(s); experience creating clinical development plan in women’s health, immunology, dermatology, internal medicine or neurology areas, including orphan conditions