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Company Description
Entrepreneurial Verve, Rooted in Tradition. At MT Pharma America, we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma, 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.
Job Description
The Director of Medical Science/Translational Research (MS/TR) will join our evolving Medical Science/Translational Research team in Clinical Research to investigate indications (i.e. how to clinically use a molecule) and create clinical development for new molecules that were discovered in Mitsubishi Tanabe Pharma Corporation laboratories or found in in-license activities. The expected therapeutic areas will be immunology, dermatology, internal medicine or neurology including orphan conditions.Director, MS/TR provides a vital role to the global organization by facilitating the team in integrating basic science, regulatory requirements and commercial insights, operational feasibility to select target indication and creation of clinical development strategy. At MTDA, the Director of MS/TR supports many project initiatives across multiple therapeutic areas relevant to in-house pipeline coming from MTPC laboratory (small molecules or biologics), collaboration with academia, early phase clinical development (Proof of Concept), re-purposing of a drug already marketed in Japan and product commercialization/post-marketing studies in the US.
Duties:
The responsibilities will vary based on products' life cycles, but will include the following:•
Propose target indications of a molecule and priorities after experts outreach in collaboration with medical affair/scientific liaison and thorough assessment of opportunities and risks with a team.•
Evaluate opportunity and risks for license-in candidate compound, create potential clinical development strategy with a team and write a briefing report.•
Create clinical development strategy and high-level integrated development plan with a team after deep analyses of non-clinical and clinical evidence (in-house data and literature), CMC, medical needs, regulatory requirement and operational feasibility.•
Facilitate communication between US partner including academia and MTPC in Japan to collaborate for clinical development opportunities and create project plan for moving forward efficiently.•
Write scientific rationale, integrated development plan, clinical protocol synopsis and abstract as needed.
Collaborate with internal staff from multiple functions in MTDA, consultants and CROs. Communicate with Europe and Japan (MTPC).•
Attend and support scientific and medical meetings by providing data and scientific background.
Qualifications
Minimum of 5 years of industry experience (Pharmaceutical, Biotech or related field).•
Minimum of 3 years of hands-on experience to create clinical development strategy and/or integrated development plan after deep understanding and evaluation of nonclinical data, CMC, regulatory, marketing and operational feasibility.•
Minimum of 3 years of hands-on experience to design clinical studies, write protocol synopsis or scientific rationale in regulatory documents.•
Understanding of pharmacokinetics, statistical analyses and regulatory requirement. •
Ability to quickly digest scientific information, regulatory requirement, marketing opportunity/challenge and operational challenge in several stages of projects in a new therapeutic area, with literature search and peer-to-peer team learning environment.•
Excellent presentation skills, networking, collaboration and ability to work in a team environment.• Experience communicating with global counterparts.•
Strong analytical, interpersonal skills, evaluative, verbal and written skills.•
Ability to organize, prioritize, and work effectively in a dynamic environment.•
Ability to travel 10-20% of the time, or as needed.•
Preferred: Experience filing NDA(s) •
Preferred: Experience creating clinical development plan(s) in immunology, dermatology, internal medicine or neurology areas including orphan conditions
Additional Information
Our Value Proposition:
Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, MT Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits:
Medical/Dental / Life Insurance / Supplemental Life Insurance/Dependent Life Insurance / Accidental Death & Dismemberment Insurance / Business Travel Accident Insurance / Short-Term Disability / Long-Term Disability / Flexible Spending Accounts / Employee's Savings Plan (401K Plan) / Competitive Paid Time Off