Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.
Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.
Recognitions
Named Science's Top Employer in 2021, 2022, and 2023
Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for three years in a row.
A Certified Great Place to Work®
We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.
Overview
The Executive Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead clinical programs across different diseases and supervising the clinical development team. This individual will be the primary point person for medical monitoring and oversight of assigned clinical programs including monitoring of clinical studies, review & interpretation of clinical trial data, authoring clinical study and regulatory communications and documents, and monitoring of competitor activities and data. This individual will play a crucial role in formulating the company's ophthalmology pipeline and portfolio expansion, working closely with the research and commercial departments.
Responsibilities
Designing and implementing the clinical development strategy and clinical protocols and delivering high quality clinical programs, from first-in-human trials, through 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, etc., and serve as primary, point of escalation for all issues identified which may affect the quality and integrity of clinical studies.
Medical monitoring, coding, and data cleaning 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.
Preparing safety charters, DMC charters, or other specific management plans and manuals in a cross-functional team.
Supporting or preparing data interpretation and clinical trial reports.
Preparing Investigator Alert letters and SAE reports in collaboration with Clinical Operations as required.
Represent the company to external stakeholders supporting the conduct of clinical trials, including CROs, clinical consultants, investigational sites, etc.
Analyze, interpret, and organize data for presentations and publications
Interact with external experts to gather input
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
Develop and manage budgets required to implement clinical development plans, and regularly report plan progress to stakeholders.
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.
Support business development, potential product evaluation, and due diligence.
Provide medical/clinical expertise to internal (Marketing, Sales, Manufacturing, Market Access, Patient Services, Regulatory Affairs, R&D, and Legal) and external (healthcare professionals, data safety monitoring boards, patients, advocacy groups, etc.) customers.
Coach, manage, and mentor direct reports, while providing job enrichment and developmental opportunities.
Job Requirements:
Required: MD, DO, or foreign equivalent, with clinical experience
Preferred: A PhD in addition to the above
10+ years of management experience in ophthalmology clinical development.
Pediatric experience preferred.
Gene Therapy experience preferred
Clinical residency training in ophthalmology
Experience with retinal diseases
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
Domestic and/or International travel required 20%
Travel Requirements
Domestic and/or International travel required 20%
Salary Range
344000-412866.67
Compensation & Benefits
We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:
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
ADDITIONAL U.S. BENEFITS:
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 on-line 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
Additional Information
Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
Applications are accepted for 5 calendar days from the date posted or until the position is filled.
