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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 https://www.us.sumitomo-pharma.com 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 - Leads and drives strategy for clinical development programs for assigned asset(s) within the neurology therapeutic area. - Leads or joins multi-disciplinary, multi-regional, matrix team through highly complex decisions. - Responsible for and lead all activities related to clinical study design from study concept to study protocol for both early- and late-stage programs. - Provides oversight of clinical trial conduct, interacting with CROs, medical monitors, and vendors as required. - 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. - Study-level, site-level and subject-level data review and interpretation, including documentation and summarization of findings. - Serve as the internal medical monitor for clinical trials. - Close collaboration with Pharmacovigilance department to ensure adequacy of safety monitoring and reporting. - Review and provide input for the design of the statistical analysis plans, TLFs, and the clinical data output. - Contributes to interpretation of clinical trial results and the writing of clinical study reports. - Contributes to the preparation of Investigator Brochures, annual reports, data collection systems and final reports in compliance with appropriate scientific/regulatory/medical standards. - Contributes to developing clinical components of BLA/NDAs, sNDAs, MAAs and other regulatory filing documents. - Contributes to company responses to health authorities and ethics committees for ongoing clinical development programs to ensure timely registration and initiation of trials globally. - Contributes to the development of presentation materials for investigator meetings, health authority meetings, scientific advisory board meetings, and national and international scientific meetings. - Serve as the subject matter expert for neurology, representing Clinical Research to both internal and external customers. - 20% domestic and international travel. Key Core Competencies - Knowledge and understanding of FDA, GCP, and ICH regulations and guidance. - Thorough and up-to-date knowledge of therapeutic area including trends, advances, understanding of currently available therapies and competitive clinical landscape. - Experience in conducting global clinical trials in both early- and late-stage clinical development, especially protocol development and trial initiation. - Experience in regulatory submissions in US; preferred experience in Europe and Japan. - Demonstrated ability to set clear priorities, lead, influence and build consensus in a multi-disciplined team environment. - Strong team leadership skills and ability to motivate large multi-functional teams. - Ability to effectively synthesize, interpret and present scientific information to both internal stakeholders and external medical community. - High degree of organizational awareness, ability to connect the dots to understand all the interdependencies and big picture. - Excellent interpersonal and communication skills with the ability to balance multiple tasks and work within a multi-disciplinary team. Education and Experience - MD (or international equivalent). - Board certified or board eligible in neurology. - Fellowship training in epilepsy preferred. - Experience in pediatrics preferred. - A minimum of 5 years' experience in the pharmaceutical industry, with experience as Clinical Research Lead in neurology therapeutic area. - Experience in regenerative cell medicine or gene therapy preferred. - 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 wi
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