Sr. Director, Clinical Development – Early Development Team Leader (EDTL) (FT)

US-NJ-Jersey City
ID
2017-1057
# of Openings
1
Category
Clinical Development

Overview

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America, 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.

 

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.

Responsibilities

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 EOP2
  • 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

    • An advanced degree (e.g., MD/PhD, PhD or PharmD) is required
    • 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 cross functional team for clinical development including non-clinical, clinical, data science, regulatory and CMC staff; and communicating with FDA and/or EMA
    • Proven history of drug R&D successes as evidenced in publications and regulatory success milestones (EOP2, NDA)
  • Preferred: Experience filing NDA(s); experience creating clinical development plan in women’s health, immunology, dermatology, internal medicine or neurology areas, including orphan conditions 

 

    • Proficient in designing/writing phase 1 and 2 clinical study protocols, and comfortable supporting the writing of sections from IB/IND/CTA or other regulatory dossiers as needed
    • Good understanding of FDA regulatory, ICH, and GCP requirements
  • Proven ability to use well-honed influencing skills in a matrix organization to help teams achieve project milestones

 

  • Superior interpersonal skills and the ability to work across company disciplines and functional units
  • Excellent communication skills, both verbal and written
  • Willingness to travel up to 30-50% domestically and internationally

 

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, Mitsubishi Tanabe Pharma Development 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

 

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