Job Abstract

Job ID

2024-1860

# 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 Medical Science, the Senior Director, Medical Science – Early Stage will lead the early-stage development team(s) in designing, planning, implementing and executing clinical development plans and programs in accordance with company processes, SOPs, and FDA/ICH guidelines and regulations. The incumbent will lead the successful delivery of early-stage clinical milestones such as Pre-IND, phase 1 and phase 2A for the company, drawing on expertise in clinical and regulatory strategy and requirements, both local and international, related to the clinical medicine and drug development processes. He/she will be the clinical lead for large global, multidisciplinary teams, mentoring and motivating individual team members, to meet overall corporate objectives leading to submission for world-wide marketing applications. Therapeutic areas may vary, and the pipeline candidates may be small molecules or biologics covering various therapeutic areas involving complex indications including rare disease/orphan conditions.

The Senior Director, Medical Science – Early Stage will be responsible for clinical development projects, successful outcome, clinical program oversight, and support of clinical interactions with regulatory agencies. This will involve leading the design, implementation, monitoring, analysis, and reporting of clinical studies supporting his/her program.

• Working closely with the Global Development Office (GDO), Project Manager, plan and manage the project timelines, the project budget and the human resource requirements against the governance approved development plan and resources. Represent the project at senior management and governance stage-gate approval meetings.
• Actively participates in writing the protocols and statistical analysis plans (SAPs) following the directives provided by the GDO.
• Support flawless implementation and operational aspects of clinical trial execution, data management and data analysis in partnership with Global program and project leaders from various functional lines.
• Lead clinical/scientific expertise for development of effective commercial and marketing strategy.
• Working closely with Marketing and Medical Affairs, define the publication strategy.
• Guide content of important clinical and regulatory submissions supporting clinical programs for all stages of development.
• Collaborate with KOLs as needed to for clinical/regulatory strategy, Health Authority Advisory meetings, development of target indications, clinical development plans, study designs and program feasibility.
• Lead program specific team meetings/presentations with senior management in US, EU and Japan as needed.
• 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.
• Collaborates with, communicates with, and as required oversees the work of external service providers or suppliers directly involved in the drug development process.
• Complies with all the Quality Assurance requirements and internal compliance rules and Regulatory rules required for clinical research in human subjects.
• Draft and review presentations for professional meetings hosted by MTDA on a global basis.

• MD or MD/PhD is required
• Minimum of 12-15 years clinical development experience, preferably some experience in large pharmaceutical companies, including a strong background in rare disease development and clinical trial design including pediatric programs.
• Minimum of 5 years of hands-on experience: leading a large, global cross functional teams for product development with evidence of success for obtaining EOP2 and/or MAA/NDA.
• Proven history of early-stage drug R&D successes as evidenced in documented regulatory success milestones (IND, Phase 1 and Phase 2A) and publications.
• High level of expertise in drug development under setting of 505(b)(1), fast track, accelerated approval and breakthrough therapy. BLA and/or 505b2 experience is a plus.
• Experience in orphan diseases and genetic-metabolic area is preferred.
• Experience managing/leading global, KOLs & cross-functional teams is required.
• Experience in HEOR (Health Economic Outcomes Research).
• Experience in PRO (patient reported outcome) Measures.
• Experience in oral formulations clinical development programs, IV development experience is a plus.
• A highly analytical and scientific mind coupled with business acumen; thinks both strategically and tactically.
• Well-honed project management skills with proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines.
• 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.
• Attention to detail and commitment to high quality and on-time deliverables.
• Outstanding computer skills.
• Required to travel up to 40% 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 $213,000 - $362,000. 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.