Senior Director, Clinical Operations

Mitsubishi Chemical Group Senior Director, Clinical Operations Jersey City, New Jersey Apply Now

Entrepreneurial Spirit, Rooted in Tradition . Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Japan’s most respected - is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach.

MTPA is rapidly expanding its operations across all functional areas. MTPA’s commitment to patients and their communities continues with a robust late-stage pipeline of investigational treatments for difficult-to-treat diseases and commercializing products with significant unmet medical needs in North American markets.

As a senior member of Clinical Operations, the Senior Director, Clinical Operations 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.

Responsibilities

1. Accountable for successful execution of clinical studies and programs to meet pertinent timelines and clinical milestones while adhering to company SOPs and applicable regulations.
2. Demonstrates a high level of expertise with operational processes and requirements, and effectively applies this knowledge to lead the clinical operations department to achieve corporate objectives.
3. Reviews master service agreements, statements of work, and quality agreements relating to clinical projects.
4. Identifies, evaluates, selects, manages, and provides oversight of CROs/other contractors; ensures senior CRO management is appropriately involved with key studies.
5. Identifies and implements innovative solutions to resolve roadblocks in patient recruitment and clinical trial execution via development of an overall outsourcing strategy including CRO management.
6. Utilizes robust and creative approaches to maximize the value of CRO activities with a rigorous approach on budgetary control.
7. Develops the clinical operations strategy including risk management and contingency planning.
8. Collaborates with QA to ensure that clinical trials meet regulatory requirements and are inspection ready.

Qualifications

1. Bachelor’s Degree in life sciences required.
2. Advanced degree (masters or doctorate level) is a plus.
3. Minimum of 15 + years of pharmaceutical or biotechnology industry experience, minimum of 8 years of clinical study management experience.
4. Strong experience in vendor management, leading CROs/various contracted resources, site monitoring and clinical quality compliance, and managing clinical trial budgets and clinical finance activities.
5. Demonstrated expertise in clinical operations development and strategic planning; experienced with early-stage clinical trials is preferred, and with the IND to NDA process.
6. Excellent working knowledge of FDA, EMA, PMDA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical operations best practices.
7. Strong team player with outstanding communication skills.
8. Willingness to travel up to 20% including domestic and international travel.

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.

The salary range for this position is $240,000-270,000. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills, internal peer equity, as well as market and business considerations may influence base pay offered.

This position is eligible to participate in our annual Short-Term Incentive (STI) program and Long-Term Incentive (LTI) program.

Job Locations US-NJ-Jersey City

Job ID 2024-1894

# of Openings 1

Category Clinical Operations, Project Management & Sourcing

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.