Director, Translational Medicine (US Remote)

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 Japans 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 Parkinsons (PD), Spinal Cord Injury (SCI), and in high unmet areas in Immunology and Oncology.

MTPA is rapidly expanding its operations across all functional areas. MTPAs 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.

The Director, Translational Medicine (TM), will be primarily responsible for creating plans for early clinical development and implementing translational plans that are aligned with companys disease and pathway strategies. The successful candidate will be responsible for shaping the strategic vision for programs and in creating and implementing experimental medicine studies. This role will partner with translational research to engage in external interactions with academic institutions having strong capabilities in translational studies and with external scientific experts.

Reporting into the Senior Director of the Translational Medicine (TM) group, the Director, TM will lead clinical and scientific aspects of translational studies from Phase 0 through Proof-of-Concept studies. In this role, the Director, TM, will contribute to accelerating the companys pipeline from portfolio entry to Proof-of-Concept (PoC). The Director, TM, should have expertise in one or more of the TM areas: early-stage clinical development, biomarker development, precision medicine, and disease biology research.

The Translational Medicine group of Early Clinical Development serves as a pivotal bridge between Discovery/Translational Research and the later phase Clinical Development group. It provides the necessary scientific and clinical expertise to advance an industry-leading pipeline of novel mechanism small molecules and biologic agents to address unmet need in immunology, neurology, and other rare diseases. This position will play a dual role, contributing both scientific and early clinical development expertise.

Responsibilities:

• Designs and executes early clinical trials through PoC including Phase 1 (safety) and Phase 2a (early efficacy studies) in healthy volunteers and the target patient population.
• Collaborates with cross functional teams (Biostatistics, Clinical Operations, Data Management, Regulatory, PK/ADME, Pharmacovigilance, Commercial) during design, execution, and reporting of early-stage clinical trials.
• Closely collaborates with translational research team on the development and implementation of clinical biomarker and patient segmentation strategies.
• Designs requests for proposals (PFR) for CROs, provides oversight of CRO selection and contract executions with clinical CRO and multiple vendors/ sub CROs as needed.
• Prepares and/or directs the preparation and review of study protocols, clinical study reports and translational medicine sections of Translational plans, IBs, INDs, abstracts, manuscripts, and technical reports.
• Participates in the planning, coordination, and oversight of internal teams for successful execution, analysis, interpretation of results of early-stage clinical studies.
• Leads or participates in cross-functional working groups such as scientific and safety review boards.
• Identifies and collaborates with academic translational sites to optimize the translational strategy and plans for programs.
• Responsible for presentation of results and updates of projects at department, project, corporate and scientific meetings.
• Collaborates with colleagues from Development and Mitsubishi Tanabe Pharma Corporation (MTPC, Japan) to support research and product development activities, including evaluation of target indications, support the development of target product profiles for early clinical development

Qualifications:

• Advanced Degree in Life Sciences (PhD, MD or MD/PhD) is required.
• Minimum of 8 years of industry experience (Pharmaceutical, Biotech, or related field). Minimum of 5 years or early clinical development or translational medicine in industry.
• Expertise in conducting Phase 1 and Phase 2a clinical trials in healthy subjects and/or in neurology, oncology, immunology and inflammation disease populations in industry is required.
• Experience in interactions with cross functional team members including clinical operations, data management, regulatory members, pharmacovigilance, translational medicine and others are required.
• Hands on experience in medical monitoring, interactions with clinical CROs, preparation of the study protocols and other relevant documentations is highly desirable.
• Experience in analyzing and presenting results of clinical studies to senior leadership/ KOLs/ medical communities and regulatory agencies is strongly preferred.
• In-depth knowledge in immunology, neurology, rheumatology, oncology and rare diseases is strongly preferred.
• Experience in designing and development of the asset from non-clinical safety efficacy data to implementation in the clinical safety, including demonstration of early efficacy
• and safety with incorporation of applicable clinical outcome assessments and biomarker endpoints in clinical study is desirable.
• Experience in interactions with patient advocacy groups, data safety monitoring boards and KOLs is a plus.
• Proven competence in clinical therapeutics, and strategic resource management
• Thorough understanding of the FDA, and ethical guidelines relevant to the pharmaceutical industry
• Able to rapidly learn new therapeutic areas in a self-taught and peer-to-peer team learning environment.
• Excellent communications skill set: verbal, written, and presentation must be of outstanding quality and clarity. Native, or near native-level English language proficiency is
• required, with additional secondary language skills (in particular, Japanese language is a plus)
• Exceptional interpersonal skill set: must possess the ability to interact amicably and professionally with all individuals at all levels of skill and experience, and across worldwide cultures, within the universe of pharmaceutical development. Must be capable of networking to discover and utilize resources critical to job performance and success.
• Conscientious, enthusiastic team player with excellent collaboration and teamwork abilities
• Strong analytical and evaluative skills
• Able to organize, prioritize, and work effectively in a constantly changing environment.
• Computer skills:
  
  • Ability to interface effectively with a variety of technical platforms for the collection, review, and dissemination of medical information.
  • Strong knowledge of MS Office (Word, PowerPoint, Excel).
• Required to travel up to 30% of the time (domestic and international), or as needed.

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 | Employees Savings Plan (401K Plan) | Competitive Paid Time Off

The salary range for this position is $155,000 - $264,000. 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.