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Senior Director, Global Clinical Development

Company: Mitsubishi Tanabe Pharma Development America Inc.
Location: Jersey City
Posted on: September 17, 2020

Job Description:

Careers – Mitsubishi Tanabe Pharma America, Inc. – Senior Director, Global Clinical Development (MT - 1186) in Jersey City, New Jersey | Careers at New Jersey Office Please Enable Cookies to Continue Please enable cookies in your browser to experience all the personalized features of this site, including the ability to apply for a job. Welcome page Returning Candidate? Log back in! Senior Director, Global Clinical Development (MT - 1186) Job Locations US-NJ-Jersey City ID 2020-1439 # of Openings 1 Category Clinical Development Overview 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.

As a senior member of Clinical Development, the Senior Director, Clinical Development will lead the early to late stage development team(s) in designing, planning, implementing and executing clinical development plans and programs in accordance with company processes, SOPs, and FDA/ICH guidelines and regulations. The incumbent will lead the successful delivery of late stage clinical milestones such as EOP2, NDA and MAA for the company, drawing on expertise in clinical and regulatory strategy and requirements, both local and international, related to the clinical medicine and drug development processes. He/she will lead large global, multidisciplinary teams, mentoring and motivating individual team members, to meet overall corporate objectives leading to submission for world-wide marketing applications as well as launch preparation and execution. Therapeutic areas may vary based on priorities of the current pipeline; however, experience with rare diseases associated with CNS, auto-immune and neuromuscular disorders is desired.

The Senior Director, Clinical Development will be responsible for clinical development strategy, clinical program oversight, and oversight of clinical interactions with regulatory agencies. This will involve leading the design, implementation, monitoring, analysis, and reporting of clinical studies supporting his/her program. He/she will also lead/participate in developing the long-range strategic plans and commercial planning.

Responsibilities Working closely with the development team Project Manager, plans and manages the project timelines, the project budget and the human resource requirements against the governance approved development plan and resources.

Leads program specific team meetings/presentations with senior management and governance committees in US, EU and Japan as needed.

Oversees critical design and analytical aspects of clinical development plans, protocols and statistical analysis plans (SAPs).

Oversees strategy and support operational aspects of clinical trial execution, data management and data analysis in partnership with Global program and project leaders from various functional lines.

Leads clinical/scientific expertise for development of effective commercial and marketing strategy.

Working closely with Marketing and Medical Affairs, defines the publication strategy.

Guides content of important clinical and regulatory submissions supporting clinical programs for all stages of development.

Collaborates with KOLs as needed to for clinical/regulatory strategy, Health Authority Advisory meetings, development of target indications, clinical development plans, study designs and program feasibility.

Evaluates, interprets, and presents complex scientific clinical data as required for senior management on a global basis.

Supports regulatory safety reporting for clinical programs: SAE assessment, queries and follow-up, annual reports and investigator brochures.

Drafts and reviews presentations for professional meetings hosted by MDTA on a global basis.

Qualifications MD or MD/PhD with exceptional development experience

Minimum of 12-15 years clinical development experience, preferably some experience in large pharmaceutical companies, including a strong background in development planning and clinical trial design.

Minimum of 5 years of hands-on experience leading a global cross functional team for clinical development with evidence of success for obtaining EOP2 and/or NDA/MAA.

High level of expertise in drug development under setting of 505(b)(1), fast track, accelerated approval and breakthrough therapy . BLA and/or 505b2 experience is a plus.

Proven history of late stage drug R&D successes as evidenced in documented regulatory success milestones (EOP2, NDA, MAA).

Experience managing/leading global, KOL’s and cross-functional teams.

Experience in HEOR (Health Economic Outcomes Research)

Experience in PRO (Patient Reported Outcome) Measures

Experience with IV and oral clinical development programs

Preferred experience: orphan diseases and movement disorders, clinical pharmacology supporting IV/oral formulation development programs

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Keywords: Mitsubishi Tanabe Pharma Development America Inc., Jersey City , Senior Director, Global Clinical Development, Other , Jersey City, New Jersey

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