Director, Medical Science - Early Stage

$190,000 - $230,000/Yr

Mitsubishi Tanabe Pharma - Jersey City, NJ

Full-time - Senior

Jersey City, NJ

Chemical Manufacturing

About the position

Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which has a storied reputation of over 300 years. MTPA is rapidly expanding its operations across all functional areas, with a commitment to patients and their communities through a robust late-stage pipeline of investigational treatments for difficult-to-treat diseases. The Director, Medical Science MSES, will be primarily responsible for creating plans for early clinical development and implementing Early Development plans aligned with the company's disease and pathway strategies. This role involves leading clinical and scientific aspects of Early Development studies from Phase 0 through Proof-of-Concept studies, contributing to accelerating the company's pipeline from portfolio entry to Proof-of-Concept (PoC). The Director, MSES, should have expertise in early-stage clinical development, biomarker development, precision medicine, and disease biology research.

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.
• 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 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.

Requirements

• 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 Early Development research in industry.
• In-depth knowledge in immunology, neurology, rheumatology, oncology 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.
• Exceptional interpersonal skill set: must possess the ability to interact amicably and professionally with all individuals at all levels of skill and experience.
• 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.
• Strong knowledge of MS Office (Word, PowerPoint, Excel).

Nice-to-haves

• Additional secondary language skills (in particular, Japanese language is a plus).

Benefits

• Medical and Dental health benefits.
• Short-term and long-term disability plans.
• Company Paid and Supplemental Life insurance.
• Critical Illness Insurance.
• Accident Insurance.
• Legal Plan.
• ID Theft Protection.
• Generous PTO policy based on tenure, commencing with 24 PTO days, pro-rated based on hire date.
• Eligible to participate in annual Short-Term Incentive (STI) program.
• Eligible to participate in Long-Term Incentive (LTI) program.