Job Abstract

Job ID

2024-1863

# of Openings

1

Category

Medical Science & Translational Research

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), and amyotrophic lateral sclerosis (ALS).

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 diseases treatments including RADICAVA® (edaravone) injectables in 2017, EXSERVAN™ (riluzole) oral film in 2021, and RADICAVA® (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, 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 MSLS Development, the Senior Director, MSLS 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

The Senior Director, MSLS will be responsible for MSLS 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.

• Oversee critical design and analytical aspects of clinical protocols and statistical analysis plans (SAPs).
• Oversee planning and support operational aspects of clinical trial execution, data management and data analysis in partnership with program operations managers.
• Responsible for the flawless and high-quality execution of the clinical trials as well as for the data collection, review and cleaning.
• Provide education and advise to the project teams in Medical Science, review and improve the clinical trials protocols and documents intended for regulatory submission.
• Complies with all regulatory, compliance, policies and good clinical practices.
• Guide content of important clinical and regulatory submissions supporting clinical programs for all stages of development.
• Build and maintain relationships with Key Opinion Leaders and recognized thought leaders.
• Lead program specific team meetings/presentations with senior management in US, EU and Japan as needed.
• Assemble, evaluate, interpret, and present complex scientific clinical data as required for senior management on a global basis.
• Support regulatory safety reporting for clinical programs: SAE assessment, queries and follow-up, annual reports and investigator brochures.
• Draft and review presentations for professional meetings hosted by MTPA on a global basis.

• MD, PhD or equivalent is required.
• 15 years of clinical development experience, with a strong background in clinical trial design and execution
• Proven history of drug R&D successes as evidenced in publications and regulatory success milestones (EOP2, NDA).
• Experience in neuroscience, immunology and rare diseases is preferred. Experience managing/overseeing staff and leading global, cross-functional teams.
• High level of expertise in the clinical and regulatory requirements, both local and international, of the clinical medicine and drug development processes.
• 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.
• Superb leadership, mentoring and motivational skills; able to marshal teams to achieve goals.
• Well-honed project management skills; proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines.
• Attention to detail and commitment to high quality and on-time deliverables.
• A highly analytical and scientific mind coupled with business savvy; thinks both strategically and tactically.
• Outstanding computer skills including MS Office.
• Willingness to travel up to 50% domestically and internationally.

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, MTDA offers our employees outstanding 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

The salary range for this position is $194,000 - $329,000. 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 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.

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.