Senior Director, Clinical Operations

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Job description

Overview:
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. MTPC has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis (MS), diabetes mellitus (DM), amyotrophic lateral sclerosis (ALS), and is currently developing medicines in Neurology in Parkinson's (PD), Spinal Cord Injury (SCI), and in high unmet areas in Immunology and Oncology.

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. In the United States, MTPA launched rare disease treatments including RADICAVA (edaravone) injectables in 2017 and RADICAVA (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, supply chain, and business development functions. MTPA is dedicated to improving the treatment environment for those with debilitating diseases, researching on real-world evidence, and creating hope for all facing illness.

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. He/she will lead teams, mentoring and motivating individual team members, to meet overall corporate objectives leading to submission for world-wide marketing applications.

The Senior Director, Clinical Operations will be responsible for clinical development strategy, clinical program oversight, and support of clinical interactions with regulatory agencies. He/she will also participate in developing the long-range strategic plans and commercial planning and lead the design, implementation, monitoring, analysis, and reporting of clinical studies supporting his/her program.

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, and effectively applies 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 Execute 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.

Qualifications:
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)

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.

MTP provides a competitive benefits package inclusive of Medical and Dental health benefits, short-term and long-term disability plans, Company Paid and Supplemental Life insurance and additional voluntary benefits such as Critical Illness Insurance, Accident Insurance, Legal Plan, and ID Theft Protection. In addition, we provide a generous PTO policy based on tenure, commencing with 24 PTO days, pro-rated based on hire date.

The salary range for this position is $(phone number removed). 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 salary may be subject to a geographic adjustment (according to a specific city and state and depending on the role), if an authorization is granted to work outside of the location listed in this posting.

This position is eligible to participate in our annual Short-Term Incentive (STI) program. Specific information about the plan including eligibility rules and target, will be furnished upon hire.

This position is eligible to participate in our Long-Term Incentive (LTI) program. Specific information about the plan including eligibility rules and target, will be furnished upon hire.

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