Senior Medical Director, Clinical Research; Ophthalmology

Job Overview

Sumitomo Pharma America (SMPA) is recruiting a Senior Medical Director, Clinical Research (Ophthalmology) to lead the design and execution of our stem cell program within the Ophthalmology therapeutic area within our R&D organization.

• Lead all clinical study design activities from concept to protocol for both early- and late-stage programs.
• Drive strategy for clinical studies for assigned asset(s) within the Ophthalmology therapeutic area.
• Provide oversight of clinical trial conduct, interacting with CROs, medical monitors, vendors and safety group to ensure adequate safety monitoring and reporting.
• Contribute to study set-up and design, including data collection tools, eCRF design, vendor database design plans and edit checks.
• Review study-level, site-level and subject-level data and summarize findings.
• Serve as internal medical monitoring for clinical trials.
• Review and provide input for the design of statistical analysis plans, clinical reports and TLFs.
• Contribute to the writing of clinical study reports, investigator brochures, annual reports, and final reports in compliance with scientific and regulatory standards.
• Contribute to the development of clinical components of BLA/NDAs, sNDAs, MAAs and other regulatory filing documents.
• Represent Clinical Research to internal and external customers as subject matter expert for ophthalmology.
• Travel: 20% domestic and international.

• Knowledge of FDA, GCP, ICH regulations and guidance.
• Up-to-date understanding of the therapeutic area, including trends and the competitive landscape.
• Experience conducting global clinical trials in both early- and late-stage development, especially protocol development and trial initiation.
• Experience in regulatory submissions in the U.S.; preferred experience in Europe and Japan.
• Demonstrated ability to set clear priorities, lead, influence and build consensus in a multi‑disciplined team.
• Strong team leadership and motivation skills for large, multi‑functional teams.
• Excellent interpersonal and communication skills with ability to synthesize, interpret and present scientific information.

• MD (or international equivalent).
• Board certification or eligibility in ophthalmology.
• Fellowship training in vitreoretinal surgery (preferred) or retina.
• Minimum 5 years’ experience in the pharmaceutical industry as Clinical Research Lead in the Ophthalmology therapeutic area.
• Experience in regenerative cell medicine or gene therapy preferred.
• Prior experience working with Japanese organizations preferred.

Base salary range: $284,320 to $355,400. The total rewards package includes merit‑based increases, incentive plan participation, 401(k) eligibility, medical, dental, vision, life and disability insurance, and paid time off, including 11 paid holidays, 80 hours of paid sick time, and additional leave for a shutdown period in December.

Fast‑paced environment handling multiple demands. Must exercise appropriate judgment as necessary. Requires high level of initiative and independence. Excellent written and oral communication skills. Requires ability to use a personal computer for extended periods of time.

All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

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 (including the refusal to submit to genetic testing) or any other characteristic protected by law.