Senior Director, Clinical Operations

$240,000 - $270,000/Yr

Mitsubishi Tanabe Pharma Corporation - Jersey City, NJ

Full-time - Senior

Jersey City, NJ

About the position

The Senior Director, Clinical Operations at Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a pivotal role responsible for leading the full development team in the design, planning, implementation, and execution of clinical trials and programs. This position ensures compliance with company SOPs and FDA/ICH guidelines, while driving the successful delivery of late-stage clinical milestones. The incumbent will oversee clinical development strategy, manage interactions with regulatory agencies, and mentor team members to achieve corporate objectives in drug development.

Responsibilities

• Accountable for successful execution of clinical studies and programs to meet pertinent timelines and clinical milestones while adhering to company SOPs and applicable regulations.
• Demonstrates a high level of expertise with operational processes and requirements, effectively applying this knowledge to lead the clinical operations department.
• Reviews master service agreements, statements of work, and quality agreements relating to clinical projects.
• Identifies, evaluates, selects, manages, and provides oversight of CROs/other contractors; ensures senior CRO management is appropriately involved with key studies.
• Identifies and implements innovative solutions to resolve roadblocks in patient recruitment and clinical trial execution.
• Utilizes robust and creative approaches to maximize the value of CRO activities with a rigorous approach on budgetary control.
• Evaluates the balance between outsourcing and in-house approaches for various clinical development needs.
• Develops the clinical operations strategy including risk management and contingency planning.
• Implements metrics to monitor the progress of clinical projects with a focus on proactive identification of issues and implementation of appropriate corrective actions.
• Implements best practices and standards for trial management in collaboration with other members of the clinical operations team.
• Leads initiatives to build and advance the clinical department infrastructure.
• Collaborates with QA to ensure that clinical trials meet regulatory requirements and are inspection ready.
• Establishes, monitors and reports on performance standards and metrics for the execution of all clinical trials and related activities.

Requirements

• Bachelor's Degree in life sciences required; advanced degree (masters or doctorate level) is a plus.
• Minimum of 15+ years of pharmaceutical or biotechnology industry experience, with a minimum of 8 years of clinical study management experience.
• Strong experience in vendor management, leading CROs/various contracted resources, site monitoring, and clinical quality compliance.
• Demonstrated expertise in clinical operations development and strategic planning; experienced with early-stage clinical trials is preferred, and with the IND to NDA process.
• Skilled in the design and execution of controlled clinical trials, with an emphasis on early clinical development.
• Excellent working knowledge of FDA, EMA, PMDA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical operations best practices.
• Well-honed leadership skills with a strong sense of responsibility and urgency.

Nice-to-haves

• Experience with early-stage clinical trials is preferred.
• Strong line management skills (ability to attract, hire, retain, mentor, and develop staff).
• Outstanding communication skills (verbal, interpersonal, influencing, negotiation, presentation, and writing).

Benefits

• Medical and Dental health benefits
• Short-term and long-term disability plans
• Company Paid and Supplemental Life insurance
• Critical Illness Insurance
• Accident Insurance
• Legal Plan
• ID Theft Protection
• Generous PTO policy starting with 24 PTO days, pro-rated based on hire date
• Participation in annual Short-Term Incentive (STI) program
• Participation in Long-Term Incentive (LTI) program