Executive Medical Director – Ophthalmology, Clinical Development

November 17

🏖️ New Jersey – Remote

Although this job is listed in New Jersey, this company may be open to hiring remote in other states.

💵 $247k - $345.5k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Insmed Incorporated

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Biotechnology • Pharmaceuticals • Science

Insmed Incorporated is a global biopharmaceutical company that discovers, develops, and commercializes therapies for serious and rare diseases. The company focuses on innovative modalities including gene therapy with targeted delivery, protein deimmunization, RNA-based approaches, and proprietary manufacturing, and it markets approved treatments (e. g. , ARIKAYCE and BRINSUPRI) while advancing a diverse clinical pipeline and patient-centered programs.

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

📋 Description

• Design and implement the clinical development strategy and clinical protocols while delivering high quality clinical programs, from first-in-human trials to full development • Serve as the therapeutic area lead of the ophthalmology clinical development team, partnering closely with heads of clinical operations, toxicology, regulatory affairs, commercial, pharmacovigilance, clinical quality, and biostatistics • Provide medical leadership for key areas of clinical operational strategy, particularly with respect to site selection, enrollment, feasibility • Perform medical monitoring, coding, and data cleaning, and prepare Investigator Alert letters and SAE reports in collaboration with Clinical Operations • Ensure the medical integrity of clinical study reports and data interpretation/communication • Author or oversee authorship of clinical sections of regulatory submissions (INDs, briefing books, BLAs, NDAs, etc.) and represent the company at regulatory meetings including presentation at Advisory Committee Meetings • Prepare safety charters, DMC charters, or other specific management plans and manuals in a cross-functional team • Represent the company to external stakeholders supporting the conduct of clinical trials, including CROs, clinical consultants, investigational sites • Organize scientific advisory board meetings and data safety monitoring committee meetings • Maintain a high level of clinical and scientific expertise in ophthalmologic disease area(s) by reviewing the literature and attending medical/scientific meetings • Be an active participant with the gene therapy leadership team on the strategic direction of business and provide guidance on opportunities/hurdles that may be forecasted

🎯 Requirements

• Professional level degree (OD, PhD) with an MD or DO preferred • 10 years of global experience in ophthalmology clinical development within the pharmaceutical/biotech industry • Experience across multiple phases of clinical research (Phase 1-3) • Significant management experience in ophthalmology clinical development • Pediatric experience preferred • Gene Therapy experience preferred • Clinical residency training in ophthalmology • Experience with retinal diseases • Knowledge of ICH-GCP and FDA regulatory guidelines

🏖️ Benefits

• Comprehensive medical, dental, and vision coverage and mental health support • Annual wellbeing reimbursement and access to our Employee Assistance Program (EAP) • Generous paid time off policies • Fertility and family-forming benefits • Caregiver support and flexible work schedules with purposeful in-person collaboration • 401(k) plan with a competitive company match • Annual equity awards and participation in our Employee Stock Purchase Plan (ESPP) • Company-paid life and disability insurance • Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities • Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back