Executive Medical Director, Ophthalmology, Clinical Development

Company Description

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.

Overview

The Executive Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead clinical programs across different diseases and supervise 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.Qualifications/Requirements:Required: MD, DO, or foreign equivalent, with clinical experiencePreferred: A PhD in addition to the above10+ 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%.Salary Range

320000-384667

Compensation & Benefits

At Insmed, we're committed to investing in every team member's total well-being, now and in the future.
Our benefit programs vary by country but we offer the following to all Insmed team members, regardless of geographic location:

Flexible approach to how we work.Health benefits and time-off plans.Competitive compensation package, including bonus.Equity Awards (Long-Term Incentives).Employee Stock Purchase Plan (ESPP). Additional Information

Insmed Incorporated is an affirmative action and equal opportunity employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information or any other characteristic protected by law.
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