Senior Clinical Research Director, Ophthalmology

About This Role

Lead clinical teams and establish clinical development strategy for novel ophthalmologic therapeutics within Sanofi's R&D department. Provide medical and scientific expertise to cross-functional project teams and ensure successful clinical trials from early phases to life cycle management.

Responsibilities

• Provide ophthalmology focused medical and scientific expertise to cross-functional project teams for clinical studies
• Establish clinical development strategy and lead clinical teams, collaborating with medical experts and scientists
• Develop or contribute to regulatory documentation and provide clinical leadership for study start-up activities
• Provide appropriate medical input and clinical leadership for study conduct, including responses to IRBs and HA questions
• Responsible for the clinical part of regulatory documents, Common Technical Document, and health authority responses
• Serve as the medical expert in the Clinical Study team and mentor other clinical team members
• Design the global clinical development strategy and generate the Clinical Development Plan
• Lead ongoing assessment of product benefit-risk profile during development and LCM
• Implement strategies to identify, monitor, and resolve clinical program/trial issues
• Review and monitor study data and prepare/review key clinical documents (protocols, IB, CTD, STRs, publications)

Requirements

• Medical Doctor (MD) degree
• Ophthalmology residency training
• Minimum 5 years of clinical trial and/or clinical development experience
• Fluent in English (verbal and written)

Qualifications

• Medical Doctor (MD) and ophthalmology residency training
• Minimum 5 years of clinical trial and/or clinical development experience

Nice to Have

• Fellowship training
• Board certified or eligible in Ophthalmology
• Strong scientific and academic background with deep understanding of retina and eye diseases
• Clinical trial or pharmaceutical experience in ophthalmology
• Knowledge of drug development, ocular gene therapy, regulatory strategy
• Good networking ability in cross-cultural environment
• Strong interpersonal, communication, presentation, and negotiation skills

Benefits