Senior Director, Translational Medicine
Posted on Apr 5, 2021 by MT Pharma
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), 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, Translational Medicine role provides vital guidance to the global organization through the coordination of and the science driven crystallization of internal strategy with global external medical and scientific insights. The incumbent will be responsible for leading the transition of novel therapy programs from late-stage research to early clinical development, and leading his/her team to support the late stage programs in the areas of: biomarker, HEOR (Health Economic Outcomes Research), patient reported outcome measures, epidemiology, real world evidence (RWE) studies, formulation, pharmacology, ADME (Absorption, Distribution, Metabolism, Elimination) studies, and device development. The key activities will be to develop and execute the strategies to confirm clinical PoM/PoP/PoC and to identify the patients likely to respond to the development drug at the early clinical development stage by applying the state-of-art biomarker and translational approaches.
As the leader of the Translational Medicine team, provide the company leadership in designing and executing early clinical development strategy for novel therapy.
Set up and/or improve the translational medicine strategy, processes, and procedures for early stage clinical development and translational medicine strategy for late stage development.
Manage and develop Translational Medicine staff, including task assignment, employee training, job performance management and career development.
Collaborate 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, namely to support the development of target product profiles, draft prescribing information, probability of technical and regulatory success, and estimated value of developmental assets.
Lead the Translational Medicine group to validate the relevance of the target to human diseases by providing clinical expertise to the design of preclinical pharmacology experiments and by planning and executing experimental medicine clinical pharmacology studies.
Lead the development and execution of biomarker plans to create the rationale for dose selection in clinical studies and to demonstrate clinical PoM/PoP/PoC during the late research stage through to early clinical development.
Set up and manage collaborations with academia and CROs to ensure the project translational objectives are met.
Work seamlessly with internal and external experts, and other colleagues, to identify translational methodologies to drive asset development.
Proactively identify and mitigate scientific and medical gaps pertinent to assigned themes, molecules and projects through self-education, as well as through seeking out, identifying, interviewing, and scientifically critically incorporating the insights of best-in-world experts in order to augment internal corporate knowledge.
Identify and mitigate challenges related to scientific fit, unmet medical need, target population, competitive landscape, non-clinical study plans, clinical study design and development strategy in coordination with external experts and internal partners.
Attend and support scientific and medical meetings to obtain and deliver scientific, translational, medical, and innovation related insights.
Support decision making related to pre-clinical study plans. Provide critical review to preclinical stage assets and provide translational strategies to assure a smooth transition from pre-clinical to clinical stage.
Advanced Degree in Life Sciences: MD or MD/PhD in a relevant discipline
Minimum 12-15 years industry experience, preferably some experience in large pharmaceutical companies
At least 10 years in leadership roles (leading teams), and at least 3 years managing multiple direct reports
Working knowledge in broad aspects of clinical development from early to late stage. Strong expertise in two or more of the translational medicine disciplines: biomarker, pharmacology, HEOR, epidemiology, real world evidence, patient reported outcome, drug delivery device, and formulations
Proven competence in clinical therapeutics, drug development, business and market knowledge, and strategic resource management
Thorough understanding of the FDA, and ethical guidelines relevant to the pharmaceutical industry
Able to rapidly learn new therapeutic areas in a self-taught and peer-to-peer team learning environment
Excellent communications skill set: verbal, written, and presentation must be of outstanding quality and clarity. Native, or near native-level English language proficiency is required, with additional secondary language skills (in particular, Japanese language is a plus)
Exceptional interpersonal skill set: must possess the ability to interact with all individuals amicably and professionally at all levels of skill and experience, and across worldwide cultures, within the universe of pharmaceutical development. Must be capable of networking to discover and utilize resources critical to job performance and success
Unquestioned personal integrity coupled with a strong innovation focus and patient-centric attitude
Conscientious, enthusiastic team player with excellent collaboration and teamwork abilities
Strong analytical and evaluative skills
Able to organize, prioritize, and work effectively in a constantly changing environment