Senior Director, Clinical Development

  • Jersey City, NJ
  • Full-time

Company Description

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 full development team in designing, planning, implementing and executing clinical trials and programs in accordance with company SOPs, and FDA/ICH guidelines and regulations. The incumbent will lead the successful delivery of late stage clinical milestones for the company, drawing on expertise in clinical and regulatory requirements, both local and international, related to the clinical medicine and drug development
processes. He/she will lead teams, mentoring and motivating individual team members, to meet overall corporate objectives leading to submission for world-wide marketing applications.

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

Job Description

  • Oversee critical design and analytical aspects of clinical protocols and statistical analysis plans (SAPs).

  • Oversee strategy and support operational aspects of clinical trial execution, data management and
    data analysis in partnership with program operations managers.

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

  • Build and maintain relationships with Key Opinion Leaders and recognized thought leaders.

  • Lead program specific team meetings/presentations with senior management in US, EU and Japan as
    needed.

  • Evaluate, interpret, and present complex scientific clinical data as required for senior management
    on a global basis.

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

  • Draft and review presentations for professional meetings hosted by MDTA on a global basis.

Qualifications

  • MD or MD/PhD

  • 7+ years clinical development experience, preferably in large pharmaceutical companies, with a strong background in clinical trial design.

  • Proven history of drug R&D successes as evidenced in publications and regulatory success milestones (EOP2, NDA).

  • Experience in GI is preferred.

  • Experience managing/leading global, cross-functional teams is preferred.
  • High level of expertise working under local and international clinical and regulatory requirements for clinical medicine and drug development processes. 

  • Superior interpersonal skills coupled with multicultural awareness. Able to successfully establish relationships, communicate effectively within/across company disciplines, and thrive within a global, highly matrixed organization.

  • Superb leadership, mentoring and motivational skills; able to marshal teams to achieve goals.

  • Well-honed project management skills; proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines.

  • Attention to detail and commitment to high quality and on-time deliverables.

  • A highly analytical and scientific mind coupled with business acumen; thinks both strategically and tactically.

  • Outstanding writing skills.

  • Willingness to travel up to 50% domestically and internationally.

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, Mitsubishi Tanabe 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