Executive Medical Director, Ophthalmology

Insmed Incorporated - San Diego, CA

Full-time - Senior

San Diego, CA

Professional, Scientific, and Technical Services

About the position

The Executive Medical Director of Ophthalmology, Clinical Development is responsible for leading clinical programs across various diseases and supervising the clinical development team. This role involves medical monitoring, oversight of clinical studies, and collaboration with research and commercial departments to formulate the company's ophthalmology pipeline and portfolio expansion.

Responsibilities

• Designing and implementing the clinical development strategy and clinical protocols.
• Delivering high quality clinical programs, from first-in-human trials to full development.
• Serving as the therapeutic area lead of the ophthalmology clinical development team.
• Providing medical leadership for key areas of clinical operational strategy.
• Medical monitoring, coding, and data cleaning in collaboration with Clinical Operations.
• Ensuring the medical integrity of clinical study reports and data interpretation/communication.
• Authoring or overseeing authorship of clinical sections of regulatory submissions.
• Preparing safety charters, DMC charters, or other specific management plans and manuals.
• Supporting or preparing data interpretation and clinical trial reports.
• Preparing Investigator Alert letters and SAE reports in collaboration with Clinical Operations.
• Representing the company to external stakeholders supporting the conduct of clinical trials.
• Analyzing, interpreting, and organizing data for presentations and publications.
• Interacting with external experts to gather input.
• Organizing scientific advisory board meetings and data safety monitoring committee meetings.
• Maintaining a high level of clinical and scientific expertise in ophthalmologic disease area(s).
• Developing and managing budgets required to implement clinical development plans.
• Being an active participant with the gene therapy leadership team on the strategic direction of business.
• Supporting business development, potential product evaluation, and due diligence.
• Providing medical/clinical expertise to internal and external customers.
• Coaching, managing, and mentoring direct reports.

Requirements

• MD, DO, or foreign equivalent, with clinical experience.
• 10+ years of management experience in ophthalmology clinical development.
• Clinical residency training in ophthalmology.
• 10+ years of global experience in ophthalmology clinical development in pharmaceutical/biotech industry, across multiple phases of clinical research (Phase 1-3).
• Knowledge of ICH-GCP and FDA regulatory guidelines.

Nice-to-haves

• A PhD in addition to the above.
• Pediatric experience preferred.
• Gene Therapy experience preferred.
• Experience with retinal diseases.

Benefits

• Flexible approach to where and how we work, regionally based.
• Competitive compensation package including bonus.
• Stock options and RSU awards.
• Employee Stock Purchase Plan (ESPP).
• Flexible Vacation Policy.
• Generous paid holiday schedule and winter break.
• 401(k) plan with company match.
• Medical, dental, and vision plans.
• Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance.
• Company-provided short and long-term disability benefits.
• Unique offerings of pet, legal, and supplemental life insurance.
• Flexible spending accounts for medical and dependent care.
• Accident and Hospital Indemnity insurance.
• Employee Assistance Program (EAP).
• Mental Health online digital resource.
• Well-being reimbursement.
• Paid leave benefits for new parents.
• Paid time off to volunteer.
• On-site, no-cost fitness center at our U.S. headquarters.