Senior Medical Director, Clinical Research Neurology

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn. We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Medical Director, Clinical Research (Neurology) to join our R&D Organization. This individual will contribute to the design and execution of clinical development plan(s) for assigned asset(s) and serve as the Clinical Research Lead for stem cell and additional programs within the neurology therapeutic area. Job Duties and Responsibilities u00b7 Leads and drives strategy for clinical development programs for assigned asset(s) within the neurology therapeutic area. u00b7 Leads or joins multi-disciplinary, multi-regional, matrix team through highly complex decisions. u00b7 Responsible for and lead all activities related to clinical study design from study concept to study protocol for both early- and late-stage programs. u00b7 Provides oversight of clinical trial conduct, interacting with CROs, medical monitors, and vendors as required. u00b7 Provide clinical input for and participate in study set up and design including data collection tools, data analysis, eCRF design, edit checks, vendor database design plans, etc. u00b7 Study-level, site-level and subject-level data review and interpretation, including documentation and summarization of findings. u00b7 Serve as the internal medical monitor for clinical trials. u00b7 Close collaboration with Pharmacovigilance department to ensure adequacy of safety monitoring and reporting. u00b7 Review and provide input for the design of the statistical analysis plans, TLFs, and the clinical data output. u00b7 Contributes to interpretation of clinical trial results and the writing of clinical study reports. u00b7 Contributes to the preparation of Investigator Brochures, annual reports, data collection systems and final reports in compliance with appropriate scientific/regulatory/medical standards. u00b7 Contributes to developing clinical components of BLA/NDAs, sNDAs, MAAs and other regulatory filing documents. u00b7 Contributes to company responses to health authorities and ethics committees for ongoing clinical development programs to ensure timely registration and initiation of trials globally. u00b7 Contributes to the development of presentation materials for investigator meetings, health authority meetings, scientific advisory board meetings, and national and international scientific meetings. u00b7 Serve as the subject matter expert for neurology, representing Clinical Research to both internal and external customers. u00b7 20% domestic and international travel. Key Core Competencies u00b7 Knowledge and understanding of FDA, GCP, and ICH regulations and guidance. u00b7 Thorough and up-to-date knowledge of therapeutic area including trends, advances, understanding of currently available therapies and competitive clinical landscape. u00b7 Experience in conducting global clinical trials in both early- and late-stage clinical development, especially protocol development and trial initiation. u00b7 Experience in regulatory submissions in US; preferred experience in Europe and Japan. u00b7 Demonstrated ability to set clear priorities, lead, influence and build consensus in a multi-disciplined team environment. u00b7 Strong team leadership skills and ability to motivate large multi-functional teams. u00b7 Ability to effectively synthesize, interpret and present scientific information to both internal stakeholders and external medical community. u00b7 High degree of organizational awareness, ability to connect the dots to understand all the interdependencies and big picture. u00b7 Excellent interpersonal and communication skills with the ability to balance multiple tasks and work within a multi-disciplinary team. Education and Experience u00b7 MD (or international equivalent). u00b7 Board certified or board eligible in neurology. u00b7 Fellowship training in epilepsy preferred. u00b7 Experience in pediatrics preferred. u00b7 A minimum of 5 years' experience in the pharmaceutical industry, with experience as Clinical Research Lead in neurology therapeutic area. u00b7 Experience in regenerative cell medicine or gene therapy preferred. u00b7 Prior experience working with Japan organizations preferred. The base salary range for this role is $284,320 to $355,400. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. Compliance : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the

Created: 2026-03-10