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Director, Translational Medicine

Posted on Apr 6, 2021 by MT Pharma

Jersey City, NJ 07097
Research
Immediate Start
Annual Salary
Full-Time


Overview
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America, Inc. (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.


MTDA is rapidly expanding our operation across all functional areas to assist in the research and development of new products for the U.S. market.


The Director, Translational Medicine (TM), will be primarily responsible for creating and implementing program translational plans that are aligned with company's disease and Pathway strategies. The successful candidate will be responsible for shaping the strategic vision for programs and in creating and implementing experimental medicine studies. This role will partner with translational research to engage in external interactions with academic institutions having strong capabilities in translational studies and with external scientific experts.


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


The Translational Medicine group serves as a pivotal bridge between Discovery/Translational 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 clinical development expertise to TM projects.


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.
Designs and executes program translational strategies integrating both disease and Pathway approaches.
Collaborates with translational research on the development and implementation of clinical biomarker and patient segmentation strategies.
Designs and executes early clinical trials through PoC including experimental medicine studies.
Supports Business Development, including due diligence activities.
Represents TM on early and late development teams.
Represents TM for project teams when presenting to portfolio, project and governance meetings.
Leads or participates in cross-functional working groups such as scientific and safety review boards.
Identifies and collaborates with academic translational sites to optimize the translational strategy and plans for programs.
Prepares and/or directs the preparation and review of study protocols, clinical study reports and translational medicine sections of Translational 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 (MD, PhD, or MD/PhD) is required.
Minimum of 7 years of industry experience (Pharmaceutical, Biotech, or related field). Minimum of 5 years in translational medicine or translational research in industry.
In-depth knowledge in immunology, neurology and rare diseases is strongly preferred.
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 amicably and professionally with all individuals 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
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
Computer skills:
Ability to interface effectively with a variety of technical platforms for the collection, review, and dissemination of medical information
Strong knowledge of MS Office (Word, PowerPoint, Excel).
Required to travel up to 30% of the time (domestic and international), or as needed




Reference: 1152693888

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