Senior Medical Director, Clinical Research – Ophthalmology

🕒 February 18

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Sumitomo Pharma America, Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Sumitomo Pharma America, Inc. is dedicated to improving the health and well-being of people around the world by driving innovative treatments, science, and technology. The company focuses on addressing patient needs in critical areas such as psychiatry & neurology, oncology, urology, women's health, rare diseases, and cell & gene therapy. As a subsidiary of Sumitomo Pharma Co. , Ltd. , SMPA embodies the promise of combining technology and life-sciences expertise to improve patient outcomes. With a diverse pipeline of preclinical and clinical programs, SMPA is committed to delivering patient-first solutions through a technology-driven approach.

📋 Description

• Contribute to the design and execution of clinical development plan(s) for assigned asset(s) • Serve as the Clinical Research Lead for stem cell program within the Ophthalmology therapeutic area • Responsible for and lead all activities related to clinical study design • Leads or joins multi-disciplinary, multi-regional, matrix team through highly complex decisions • Provides oversight of clinical trial conduct, interacting with CROs, medical monitors, and vendors • Provide clinical input for study set up and design including data collection tools, data analysis, eCRF design, etc. • Study-level, site-level and subject-level data review and interpretation • Review and provide 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 • 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 clinical programs • Develop presentation materials for meetings and scientific conferences • Serve as the subject matter expert for ophthalmology

🎯 Requirements

• MD (or international equivalent) • Board certified or board eligible in ophthalmology • Fellowship training in vitreoretinal surgery (preferred) or retina • A minimum of 5 years' experience in the pharmaceutical industry • Experience as Clinical Research Lead in Ophthalmology therapeutic area • Experience in regenerative cell medicine or gene therapy preferred • Prior experience working with Japan organizations is preferred

🏖️ Benefits

• merit-based salary increases • short incentive plan participation • eligibility for 401(k) plan • medical, dental, vision, life and disability insurances • flexible paid time off • 11 paid holidays • additional time off during the last week of December • 80 hours of paid sick time upon hire and each year thereafter