Medical Director, Clinical Research Neurology

US-Remote

Full time

R01215

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 Linked In.

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of 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 programs within the neurology therapeutic area.

• Leads critical work streams and drives execution of clinical development programs for assigned asset(s) within the neurology therapeutic area.
• Responsible for and lead activities related to clinical study design from study concept to study protocols for programs across all stages of development.
• Provides subject matter expertise and acts as a key contributor to clinical development strategy for assigned asset(s) within the neurology therapeutic area.
• Acts as SME and provides leadership in multi-disciplinary, multi-regional, matrix team through highly complex decisions.
• 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 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.
• Responsible for KOL network development, SAB coordination and strategy, development of presentation materials for investigator meetings, health authority 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.

• 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 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…