Senior Director, Clinical Operations

$240,000 - $270,000/Yr

Mitsubishi - Jersey City, NJ

Full-time - Senior

Jersey City, NJ

Transportation Equipment Manufacturing

About the position

The Senior Director, Clinical Operations at Mitsubishi Tanabe Pharma America (MTPA) is a key leadership role responsible for overseeing the design, planning, implementation, and execution of clinical trials and programs. This position requires a deep understanding of clinical and regulatory requirements, as well as the ability to lead teams to achieve corporate objectives and meet clinical milestones. The Senior Director will also play a crucial role in developing clinical strategies and managing interactions with regulatory agencies, ensuring that clinical trials are conducted in compliance with company SOPs and applicable regulations.

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 to achieve corporate objectives.
• 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, responds to, and meets the needs of staff and internal groups.
• 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.
• 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 the various clinical development needs and works closely with the Executive Director and the VP, Clinical Operations to make recommendations for MTPA's strategy in this regard.
• 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, including establishment of SOPs.
• 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, 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, and managing clinical trial budgets and clinical finance activities.
• 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: takes personal responsibility for outcomes, thrives on increasing levels of responsibility, confidently moves the business forward, uses insightful thinking to effect organizational change and drive innovation, harnesses organizational skills and sense of urgency to motivate self and team to meet pressing deadlines in fast-paced environment, uses strong line management skills (ability to attract, hire, retain, mentor, and develop staff).
• Strong team player: displays positive attitude and 'rolls up sleeves' to contribute to team efforts, builds strong relationships with a wide range of stakeholders at all levels (e.g., Senior Executive Team, board members, KOLs, regulatory bodies, investors, peers on cross-functional and cross-regional teams, etc.).
• Outstanding communicator (verbal, interpersonal, influencing, negotiation, presentation as well as stellar writing skills and a track record of publications).

Nice-to-haves

• Experience with early-stage clinical trials is preferred.

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 based on tenure, commencing with 24 PTO days, pro-rated based on hire date.