Senior Director Clinical Development - Early Development Team Leader (EDTL)

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 Senior Director, Clinical
Development will fill a vital role in our growing organization serving as the Early
Development Team Leader (EDTL) responsible for overseeing a globally based, multidisciplinary
team responsible for successful delivery of development milestones including
IND, FIH, POC, EOP2 and NDA. In addition
to leading the Early Development Team (EDT), the individual will be responsible
for supporting the development and writing of regulatory documents (IB/IND/CTA),
study protocols and clinical development plans. The role will include oversight
of design and conduct of FIH and proof of concept studies for new molecules
that were discovered in Mitsubishi Tanabe Pharma Corporation (MTPC)
laboratories or obtained through in-license activities. Presently, the role will be responsible for
leading one or more projects with global teams including representatives from non-clinical,
clinical operations, CMC, project management
and regulatory affairs in
preclinical to Phase IIa (human proof of
concept). Therapeutic areas may vary and the pipeline candidates may be small
molecules or biologics covering broad disease markets all the way down to
narrow indications including orphan conditions.

Duties:

With respect to leadership of the
EDT, the responsibilities will vary based on the products' life cycles, but
will include the following:

• Responsibility
  for the success of a project from pre-IND to POC
• Lead the EDT to plan, execute and
  manage the early stage development projects
• Set expectations of deliverables to
  functional representatives within the team
• Working closely with the EDT Project Manager, plan and
  manage the project timelines, the project budget and the human resource
  requirements against the approved IDP and approved resources.
• Represent the project at decision-making meetings
  Additional responsibilities outside
  the EDT include the following:

• Provide scientific expertise to New Product
  Marketing Strategy
• Working closely with Marketing and Medical Affairs, define the publication
  strategy
• Working closely with all
  contributing lines of the organization, shepherd the development of an integrated
  development plan
• Assist and manage a medical writer
  for full protocol, regulatory documents or other deliverables.
• Communicate with KOLs as needed to
  for development of target indications, clinical development plans, study designs
  and program feasibility.
• Support clinical operations and regulatory
  affairs staff as needed.

Collaborate with internal staff
from multiple functions in Mitsubishi Tanabe Pharma Development America (MTDA)
(the US subsidiary of MTPC), consultants and CROs. Communicate with Europe and
Japan (MTPC).

Qualifications

Excellent communication skills, both
verbal and written

Minimum of 15 years of industry
experience (Pharmaceutical, Biotech or related field)

Minimum of 10 years of hands-on
experience: Developing a clinical development plan after deep understanding and
evaluation of nonclinical data, CMC, regulatory, marketing and clinical
operations;

Minimum of 5 years of hands-on
experience: leading a global team for clinical development including
non-clinical, clinical, data science, regulatory and CMC staff; and
communicating with FDA and/or EMA

Designing/writing phase 1 and 2 clinical
study protocols, and comfortable with supporting the writing of sections from IB/IND/CTA
or other regulatory dossiers as needed;

Preferred: Experience filing NDA(s); experience creating clinical
development plan 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