Senior Medical Director, Clinical Research Neurology

Overview

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.). The company focuses on oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. It supports a pipeline of early‑to‑late‑stage investigational assets, accelerating the delivery of novel therapies to patients worldwide.

Responsibilities

• Lead and drive strategy for clinical development programs for assigned asset(s) within the neurology therapeutic area.
• Lead or join multidisciplinary, multi‑regional, matrix teams, making highly complex decisions.
• Lead all activities related to clinical study design, from concept to protocol, for both early and late‑stage programs.
• Provide oversight of clinical trial conduct, interacting with CROs, medical monitors, and vendors.
• Contribute clinical input to study set‑up and design including data collection tools, eCRF design, edit checks, and vendor database plans.
• Review and interpret study‑level, site‑level, and subject‑level data, documenting and summarizing findings.
• Serve as the internal medical monitor for clinical trials.
• Collaborate with Pharmacovigilance to ensure adequate safety monitoring and reporting.
• Review and provide input for statistical analysis plans, TLFs, and clinical data outputs.
• Contribute to interpretation of trial results and the writing of clinical study reports.
• Prepare Investigator Brochures, annual reports, data collection systems and final reports in compliance with regulatory and medical standards.
• Develop clinical components of BLA/NDAs, sNDAs, MAAs, and other regulatory filing documents.
• Respond to health authorities and ethics committees for ongoing clinical development programs, ensuring timely registration and trial initiation globally.
• Create presentation materials for investigator meetings, health authority meetings, scientific advisory board meetings, and national and international scientific conferences.
• Act as the subject‑matter expert for neurology, representing Clinical Research to internal and external stakeholders.
• Travel domestically and internationally up to 20% of the time.

Key Core Competencies

• Knowledge of FDA, GCP, and ICH regulations and guidance.
• Current, in‑depth knowledge of the therapeutic area, including trends, advances, available therapies, and the competitive landscape.
• Experience conducting global clinical trials, especially protocol development and trial initiation.
• Regulatory submission experience in the U.S.; preferred experience in Europe and Japan.
• Ability to set clear priorities, lead, influence, and build consensus in a multi‑disciplined team environment.
• Strong leadership skills and the ability to motivate large, multifunctional teams.
• Ability to synthesize, interpret, and present scientific information to stakeholders and the medical community.
• High organizational awareness, connecting interdependencies and the big picture.
• Excellent interpersonal and communication skills, balancing multiple tasks within a multidisciplinary team.

Qualifications

• MD (or international equivalent).
• Board certified or board eligible in neurology.
• Fellowship training in epilepsy preferred.
• Experience in pediatrics preferred.
• Minimum 5 years of experience in the pharmaceutical industry, including 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.

Benefits

The base salary range for this role is $284,320 to $355,400. Compensation also includes merit‑based salary increases, short‑incentive plan participation, eligibility for a 401(k) plan, medical, dental, vision, life, and disability insurance, and state‑aligned leave policies. The time‑off policy offers flexible paid time off, 11 paid holidays (including a shutdown period during the last week of December), 80 hours of paid sick time upon hire, and additional annual paid sick time.

EEO Statement

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, domestic partnership or civil union status, sex, gender, sexual orientation, disability, veteran or military status, domestic violence victim status, atypical cellular or blood trait, genetic information, or any other characteristic protected by law.