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.

About the role

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.

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 leads 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.
• Provides clinical input for and participates in study set up and design including data collection tools, data analysis, eCRF design, edit checks, vendor database design plans, etc.
• Performs study-level, site-level, and subject-level data review and interpretation, including documentation and summarization of findings.
• Serves as the internal medical monitor for clinical trials.
• Collaborates closely with the Pharmacovigilance department to ensure adequacy of safety monitoring and reporting.
• Reviews and provides 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.
• Serves as the subject matter expert for neurology, representing Clinical Research to both internal and external customers.
• 20% domestic and international travel.

Requirements

• Knowledge and understanding of FDA, GCP, and ICH regulations and guidance.
• Thorough and up-to-date knowledge of the neurology 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 the 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 the external medical community.
• High degree of organizational awareness, ability to connect the dots to understand all interdependencies and the big picture.
• Excellent interpersonal and communication skills with the ability to balance multiple tasks and work within a multi-disciplinary team.

Qualifications

• 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 the neurology therapeutic area.
• Experience in regenerative cell medicine or gene therapy preferred.
• Prior experience working with Japan organizations preferred.

Pay

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.

Benefits

• Robust time-off policy including 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.