Senior Medical Director, Clinical Research (Ophthalmology)

Sumitomo Pharma Co., Ltd. is seeking a Senior Medical Director, Clinical Research (Ophthalmology) to lead clinical development and serve as the Clinical Research Lead for stem cell programs within ophthalmology.

Location: United States

Salary: $284,320 to $355,400

Responsibilities

• Design and execute clinical study plans from concept to protocol for early- and late-stage programs.
• Lead or participate in multi-disciplinary, multi-regional teams for complex decisions.
• Develop and drive clinical study strategies within ophthalmology.
• Oversee clinical trial conduct, liaising with CROs, monitors, vendors, and safety groups.
• Contribute to study setup, data collection tools, analysis, and database design.
• Review and interpret data at study, site, and subject levels.
• Serve as internal medical monitor for clinical trials.
• Review statistical analysis plans and clinical data outputs.
• Interpret clinical trial results and contribute to reports.
• Assist in preparing regulatory documents like Investigator Brochures, annual reports, and final reports.
• Support development of regulatory submission components (BLA/NDAs, sNDAs, MAAs).
• Assist in responding to health authorities and ethics committees.
• Develop presentation materials for various scientific and regulatory meetings.
• Act as subject matter expert in ophthalmology.
• Travel approximately 20% domestically and internationally.

Requirements

• MD or international equivalent.
• Board certified or eligible in ophthalmology.
• Fellowship training in vitreoretinal surgery or retina (preferred).
• Minimum 5 years' experience in pharmaceutical industry, with leadership in ophthalmology clinical research.
• Experience in regenerative cell medicine or gene therapy (preferred).
• Experience working with Japanese organizations (preferred).

Benefits

• Base salary range: $284,320 to $355,400.
• Merit-based salary increases.
• Participation in short incentive plan.
• Eligibility for 401(k).
• Medical, dental, vision, life, and disability insurances.
• Flexible paid time off, 11 paid holidays, additional time off during last week of December.
• 80 hours of paid sick time annually.

Additional Information

• Position involves high-level clinical research leadership in ophthalmology.
• Requires travel approximately 20%.
• Confidentiality and compliance with all regulatory and legal standards are mandatory.
• High-paced environment requiring initiative, judgment, and excellent communication skills.