Job description

Overview: Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America, Inc. (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.

MTDA is rapidly expanding our operation across all functional areas to assist in the research and development of new products for the U.S. market.

Working closely with the Director, Clinical Operations, other executive-level Clinical & Technical Operations (CTO) staff, and the Development Team Leader(s), the Associate Director, Clinical Operations oversees global clinical operational activities for MTDA, guiding activities and influencing colleagues in a highly matrixed environment. The incumbent will manage activities related to executing clinical studies in support of development programs in accordance with company SOPs, and FDA & ICH guidelines and regulations.

The Associate Director, Clinical Operations will oversee the operational strategy for trial execution, implementation, monitoring, analysis, data delivery and regulatory submission. The incumbent will lead the successful execution and timelines for clinical trials drawing on a high level of expertise with clinical and regulatory requirements, both local and international, for clinical operational processes and requirements.
Responsibilities:

• Provides 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.
• Works collaboratively with internal and external staff associated with clinical operations as well as CROs and vendors associated with operational functions.
• Recommends and/or assesses potential CROs and vendors in collaboration with Sourcing and other colleagues.
• Leads data review and discrepancy resolution, team meetings/presentations for a clinical trial with senior management, in the US, EU and Japan, as needed.
• Defines and presents complex operational objectives as required for senior management.
• Oversees data collection activities for clinical programs: CRF, SAE assessment, queries, and follow-up, annual reports, investigator brochures, NDA, etc.
• Collaborates with, communicates with, and as required oversees the work of external service providers or suppliers directly involved in the drug development process.

Qualifications:

• BS required; higher-level degree is a plus.
• Minimum of 8-10 years of increasing responsibility and success in clinical operations in a pharmaceutical company or CRO with a strong background in clinical trial design.
• Pharmaceutical or CRO experience should have demonstrated proven success in one or more complex matrix-based organizations.
• Expertise in clinical and regulatory requirements, both local and international, of the clinical medicine and drug development processes.
• Expertise in outsourcing and CRO management; outstanding budget oversight and adjudication skills.
• Highly analytical, scientific mind with exceptional problem-solving skills.
• Confident operations leader with proven ability to apply knowledge base to effectively motivate staff to achieve corporate objectives.
• Superior interpersonal skills coupled with multicultural awareness.
• Strong ability to build peer relationships, communicate effectively within/across company disciplines, cross-functional and external teams, and thrive within a global, highly matrixed organization.
• Skilled at leading external teams at remote locations.
• Well-honed project management skills. Proven ability to simultaneously manage activities associated with multiple clinical trials 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.
• Required to travel domestically and internationally.

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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, MTDA offers our employees outstanding 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

Job Type: Full-time

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