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.
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