Senior Director, Medical Science – Early Stage (Remote)

Overview

Entrepreneurial Spirit, Rooted in Tradition. Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Japan’s most respected - is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis (MS), diabetes mellitus (DM), amyotrophic lateral sclerosis (ALS), and is currently developing medicines in Neurology in Parkinson’s (PD), Spinal Cord Injury (SCI), and in high unmet areas in Immunology and Oncology.

MTPA is rapidly expanding its operations across all functional areas. MTPA’s commitment to patients and their communities continues with a robust late-stage pipeline of investigational treatments for difficult-to-treat diseases and commercializing products with significant unmet medical needs in North American markets. In the United States, MTPA launched rare disease treatments including RADICAVA® (edaravone) injectables in 2017 and RADICAVA® (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, supply chain, and business development functions. MTPA is dedicated to improving the treatment environment for those with debilitating diseases, researching on real-world evidence, and creating hope for all facing illness. 

As a senior member of Medical Science, the Senior Director, oncology group, Medical Science – Early Stage will lead the early-stage development team(s) in designing, planning, implementing and executing clinical development plans and programs in accordance with company processes, SOPs, and FDA/ICH guidelines and regulations. The incumbent will lead the successful delivery of early-stage clinical milestones such as Pre-IND, phase 1 and phase 2A for the company, drawing on expertise in clinical and regulatory strategy and requirements, both local and international, related to the clinical medicine and drug development processes. He/she will be the clinical lead for large global, multidisciplinary teams, mentoring and motivating individual team members, to meet overall corporate objectives leading to submission for world-wide marketing applications. Therapeutic areas may vary, and the pipeline candidates may be small molecules or biologics covering various therapeutic areas involving complex indications including rare disease/orphan conditions.

The Senior Director, oncology group, Medical Science – Early Stage will be responsible for clinical development projects, successful outcome, clinical program oversight, and support of clinical interactions with regulatory agencies. This will involve leading the design, implementation, …