Senior Director, Clinical Operations

• 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.

• 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.

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