Careers – Mitsubishi Tanabe Pharma America, Inc. – Senior
Director, Global Clinical Development (MT - 1186) in Jersey City,
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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
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
Oversees critical design and analytical aspects of clinical
development plans, protocols and statistical analysis plans
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
Leads clinical/scientific expertise for development of effective
commercial and marketing strategy.
Working closely with Marketing and Medical Affairs, defines the
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
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
Drafts and reviews presentations for professional meetings
hosted by MDTA on a global basis.
Qualifications MD or MD/PhD with exceptional development
Minimum of 12-15 years clinical development experience,
preferably some experience in large pharmaceutical companies,
including a strong background in development planning and clinical
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
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
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