Director, Medical Science – Early Stage

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. 

The Director, Medical Science MSES, will be primarily responsible for creating plans for early clinical development and implementing Early Development plans that are aligned with company’s disease and pathway strategies. The successful candidate will be responsible for shaping the overall plans for programs and in creating and implementing experimental medicine studies.

Reporting into the Senior Director of the Medical Science Early-Stage, the Director, MSES will lead clinical and scientific aspects of Early Development studies from Phase 0 through Proof-of-Concept studies. In this role, the Director, MSES, will contribute to accelerating the company’s pipeline from portfolio entry to Proof-of-Concept (PoC). The Director, MSES, should have expertise in one or more of the MSES areas: early-stage clinical development, biomarker development, precision medicine, and disease biology research.

The Medical Science Early-Stage group of Early Clinical Development serves as a pivotal bridge between Discovery/Early Development Research and the later phase Clinical Development group. It provides the necessary scientific and clinical expertise to advance an industry-leading pipeline of novel mechanism small molecules and biologic agents to address unmet need in immunology, neurology, and other rare diseases. This position will play a ‘dual role’, contributing both scientific and early clinical development expertise.

Responsibilities

• Collaborates with colleagues from Mitsubishi Tanabe Pharma Development America (MTDA) and Mitsubishi Tanabe Pharma Corporation (MTPC, Japan) to support research and product development activities, including evaluation of target indications, support the development of target product profiles for early clinical development.
• Closely collaborates with Early Development research team on the development and implementation of clinical biomarker and patient segmentation strategies.
• Designs and executes early clinical trials through PoC including experimental medicine studies.
• Collaborates with cross functional teams (Biostatistics, Clinical Operations, Data Management, Regulatory, PK/ADME, Pharmacovigilance, Commercial) during design, execution, and reporting of early-stage clinical trials.
• Participates in the planning, coordination, and oversight of internal teams for successful execution, analysis, interpretation of results of early-stage clinical studies.
• Leads or participates in cross-functional working groups such as scientific and safety review boards.
• Identifies and collaborates with academic Early Development sites to optimize the Early Development strategy and plans for programs.
• Prepares and/or directs the preparation and review of study protocols, clinical study reports and Early Development Medical Science Early-Stage sections of Early Development plans, IBs, INDs, abstracts, manuscripts, and technical reports.
• Responsible for presentation of results and updates of projects at department, project, corporate and scientific meetings.

Qualifications

• Advanced Degree in Life Sciences (PhD, MD or MD/PhD) is required.
• Minimum of 8 years of industry experience (Pharmaceutical, Biotech, or related field). Minimum of 5 years in Medical Science Early-Stage or