Executive Medical Director, Ophthalmology, Clinical Development

Insmed Incorporated - San Diego, CA

Full-time - Executive

San Diego, CA

Professional, Scientific, and Technical Services

About the position

The Executive Medical Director of Ophthalmology, Clinical Development at Insmed 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 multiple departments to formulate the company's ophthalmology pipeline and portfolio expansion. The position requires a strong focus on clinical strategy, regulatory submissions, and maintaining high standards of clinical integrity.

Responsibilities

• Designing and implementing the clinical development strategy and clinical protocols.
• Serving as the therapeutic area lead of the ophthalmology clinical development team.
• Providing medical leadership for clinical operational strategy, including site selection and enrollment.
• Conducting 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 and representing the company at regulatory meetings.
• Preparing safety charters, DMC charters, and other specific management plans.
• Supporting or preparing data interpretation and clinical trial reports.
• Preparing Investigator Alert letters and SAE reports as required.
• Representing the company to external stakeholders supporting clinical trials.
• Analyzing, interpreting, and organizing data for presentations and publications.
• Interacting with external experts to gather input and organizing advisory board meetings.
• Maintaining a high level of clinical and scientific expertise in ophthalmologic disease areas.
• Developing and managing budgets for clinical development plans and reporting progress to stakeholders.
• Participating with the gene therapy leadership team on strategic business direction.
• Supporting business development and product evaluation.
• 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 the 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.
• Gene Therapy experience.
• Experience with retinal diseases.

Benefits

• Flexible approach to work location and hours.
• 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 U.S. headquarters.