Vice President, Medical Science Early Development

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.

The Vice President of Early Clinical Development (VP, ECD) is a leadership position responsible for the portfolio of programs from initiation of an investigational new drug (IND) to completed proof of concept (POC) studies. The VP, ECD is responsible for the clinical oversight of all early clinical studies, and the articulation of the strategic goals of Early Development. Works closely with the Research Team in evaluating the candidate products in the preclinical stage.

The VP, ECD will be a member of leadership teams in Translational Science, Clinical Development, and participate in governance and strategic forums, maintaining the highest scientific and ethical integrity, and managing publication and communication plans. The development of disease mapping, patient centered outcomes, and integrated evidence plans for a diverse portfolio in a cross-functional is considered a key deliverable. The VP ECD is at the nexus of translational and clinical research, leveraging detailed scientific, genetic, translational, and phenotype information into a development plan that supports data-rich advancement decisions for the early portfolio.

The VP, ECD will have key strategic interfaces internally with Late-Stage Development, Translational Sciences and the Product Portfolio Team among others. Externally, this position is expected to be a dynamic catalyst for support of the pipeline and help build strong relationships with world class key opinion leaders. Success requires sound understanding of the evaluation of the scientific programs, translational results, development of key mechanistic endpoints, and leveraging early studies to understand therapeutic margins and estimates of effect size. This role is expected to contribute to portfolio growth and strategy in the context of market assessment and competitive analysis.

• Exercises oversight and responsibility for all Early Clinical Development (ECD) functions.
• Manages a motivated group of physician-scientists engaged in the programs within the ECD portfolio.
• Authors strategic content of clinical development plans and protocol development for ECD.
• Advances programs to support corporate growth goals.
• Collaborates cross-functionally with Regulatory to author strategy for first in human studies.
• Develops key internal and external stakeholder collaborations.
• Represents ECD at key research and development governance forums.
• Leads teams responsible for designing and executing early clinical programs.
• Makes impactful contributions in a cross-functional setting.
• Identifies therapeutic targets, disease mapping and pipeline strategy.
• Synthesizes and communicates results/outcomes of early clinical studies.
• Assimilates advancement of early studies into the assessment of risk and investment in programs.
• Leads external advisory process for new development programs and develops high level KOL support for key programs.
• Conducts regular interactions with senior research, senior leaders in business development, research and commercial to align development goals with functional and corporate initiatives.
• Develops early clinical trial strategies for different therapeutic areas in clinical development.
• Serves as member of the Life Cycle Management and Clinical Trial Review committees.
• Contributes to business development activities for Early Development pipeline.
• Collaborates with internal safety group in analyzing and reporting of safety data from clinical trials.
• Analyzes and interprets early clinical trial data and prepares reports for regulatory agencies and publication.
• Ensures project plans compliance, and complies with federal regulations, GCP and good medical practice.
• Collaborates with, communicates with, and as required, oversees the work of external service providers or suppliers directly involved in the drug development process. 

• MD or MD PhD with board certification, or eligibility in Oncology or Hematology/Oncology or related specialty.
• Minimum 15 years of pharmaceutical/biotech industry or a combination of academia and industry. Note: Individuals with extensive academic experience in clinical research may be considered.
• Expertise in the design, execution, and reporting of early-stage clinical trials in various indications with small and large molecule drug candidates.
• Excellent scientific knowledge relevant to early clinical development: biochemistry, immunology, molecular biology and/or genetics.
• In-depth knowledge of medical aspects of GCP, ICH, FDA, guidelines and regulations.
• Excellent leadership skills and proven ability to effectively work in a cross-functional/matrix environment.
• Leads or manages the work of others by providing guidance to subordinates based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
• Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
• Develops technical and/or business solutions to complex problems.
• Strong interpersonal, influencing, presentation, and written and verbal communication skills.
• Strong organizational and time management skills.
• Strong budget management skills.
• Ability to develop and maintain relationships with significant key opinion leaders.
• Required to travel up to 30 percent 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, 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 $333,000 - $566,000. 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.