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.

Working with closely with the Head of Clinical Development and the Development Team Leader(s), the Senior Director, Clinical Operations directs global clinical operational activities for MTDA, guiding activities and influencing colleagues in a highly matrixed environment. Concurrently, the incumbent will also directly supervise a clinical operations staff and all activities related to executing clinical studies and full development programs in accordance with company SOPs, FDA, & ICH guidelines and regulations.

The Sr. Director, Clinical Operations will lead the operational strategy for trial execution, implementation, monitoring, analysis, data delivery and regulatory submission.He/she will lead the successful execution and timelines for clinical trials and programs drawing on a high level of expertise with clinical and regulatory requirements, both local and international, for clinical operational processes and requirements

Job Description

• Lead overall operations program/team responsible for execution of global clinical program; oversee individuals managing operational execution of global clinical protocols for MTDA.
• Provide clinical trial oversight and management, vendor and CRO performance (including bid/contract, budget/adjudication) and regulatory quality delivery of MTDA clinical trials according to corporate processes and timelines.
• Participate in developing the long-range strategic plans for MTDA pipeline products and oversight of the clinical operations department.
• Supervise internal and external staff associated with clinical operations as well as CROs and vendors associated with operational functions.
• Recommend and/or assess potential CROs and vendors in collaboration with Sourcing and other colleagues.
• Lead data review and discrepancy resolution, team meetings/presentations with senior management, in the US, EU and Japan, as needed.
• Define and present complex operational objectives as required for senior management.
• Oversee data collection activities for clinical programs: CRF, SAE assessment, queries, and follow-up, annual reports, investigator brochures, NDA etc.
• Oversee management, professional development, training and performance of clinical operations staff/direct reports.

Qualifications

• MS degree or equivalent.

• Strong ability to build peer relationships and communicate effectively with company disciplines,
  cross-functional, and external teams.

• 10 years of increasing responsibility in clinical operations in a pharmaceutical company or CRO with a strong background in clinical trial design.

• Deep expertise in outsourcing and CRO management; outstanding budget oversight and adjudication
  skills.

• Successful experience in a large pharmaceutical company and complex matrix-based organization.

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

• Experience in GI programs.

• In-depth expertise in clinical and regulatory requirements, both local and international, of the clinical medicine and drug development processes.

• Highly analytical, scientific mind with exceptional problem-solving skills.

• Confident leader with proven ability to apply knowledge base to effectively manage, mentor and motivate staff to achieve corporate objectives.

• 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.

• Equally skilled at leading external teams at remote locations.

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

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

• Outstanding computer skills including MS Office.

• 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