Senior Medical Director, Neurology Clinical Research. Columbus Move Collective

Sumitomo Pharma Co., Ltd. is a leading global pharmaceutical company focused on addressing critical patient needs in various therapeutic areas, including oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS. We are dedicated to accelerating discovery and development to bring innovative therapies to patients. We are currently seeking a passionate and highly skilled individual for the position of Senior Medical Director, Neurology Clinical Research.

In this dynamic role, you will design and execute clinical development plans for assigned assets and serve as the Clinical Research Lead for stem cell therapies and additional programs in the neurology field.

• Lead and develop strategies for clinical development programs in the neurology therapeutic area.
• Participate in multi-disciplinary, multi-regional teams to navigate complex decisions.
• Oversee all aspects of clinical study design from concept to protocol in both early- and late-stage programs.
• Monitor clinical trial conduct, collaborating with CROs, medical monitors, and vendors.
• Provide clinical insights for study setup and design, including analytics and data collection tools.
• Review and evaluate study-level, site-level, and subject-level data, documenting and summarizing findings.
• Act as the internal medical monitor for clinical trials.
• Collaborate closely with the Pharmacovigilance department to ensure effective safety monitoring.
• Contribute to the design of statistical analysis plans and clinical data outputs.
• Assist in interpreting trial results and writing clinical study reports.
• Support the preparation of Investigator Brochures, annual reports, and compliance documentation.
• Contribute to the development of regulatory submission components such as BLAs, NDAs, and MAAs.
• Help prepare materials for meetings with investigators, health authorities, and scientific advisory boards.
• Serve as a subject matter expert in neurology for both internal teams and external stakeholders.
• Travel domestically and internationally up to 20% of the time.

• In-depth knowledge of FDA, GCP, and ICH regulations.
• Strong understanding of the neurology therapeutic landscape and current treatments.
• Experience leading global clinical trials with a focus on protocol development.
• Familiarity with regulatory submissions in the US, with knowledge of European and Japanese regulations preferred.
• Ability to set clear priorities and build consensus within multi-disciplinary teams.
• Excellent leadership skills to motivate cross-functional teams.
• Strong skills in synthesizing and presenting scientific data effectively.
• High organizational awareness and ability to understand interdependencies.
• Exceptional communication skills to manage multiple tasks in a team environment.

• MD or international equivalent.
• Board certification or eligibility in neurology; fellowship training in epilepsy is preferred.
• Pediatric experience is a plus.
• At least 5 years of pharmaceutical industry experience as a Clinical Research Lead in neurology.
• Experience in regenerative medicine and gene therapy is preferred.
• Prior collaboration with Japanese organizations is advantageous.

The base salary range for this role is $284,320 to $355,400. In addition to the base salary, our benefits package includes merit‑based salary increases, participation in a short incentive plan, access to a comprehensive 401(k) plan, medical, dental, vision, life and disability insurance, and a robust time‑off policy. This policy includes flexible paid time off, 11 paid holidays, additional time off during the last week of December, and paid sick leave.

Total compensation will depend on unique candidate elements such as experience, skills, and education.

Sumitomo Pharma America is an EEO employer and complies with all applicable laws prohibiting discrimination.

Applications are considered regardless of race, color, creed, religion, national origin, age, marital status, sex, gender, disability, veteran status, or any other characteristic protected by law.