Director (Ophthalmology), Clinical and Regulatory Strategic Communications (CRSC)

About the role

The Clinical and Regulatory Strategic Communications (CRSC) department within GCTO creates and delivers high-quality regulated content in support of our development pipeline and enables data sharing for our customers. We are a strategic partner that ensures excellence and compliance with applicable laws while incorporating health literacy principles in the development of public-facing materials.

Responsibilities

• Leads, envisions, and plans projects, engaging strategically with key stakeholders across departments, divisions, and company.
• Provides scientific expertise and oversight for the preparation and execution of clinical regulatory and public-facing documents across multiple programs and therapeutic areas in support of the company portfolio.
• Independently leads, manages, oversees, and/or authoring complex clinical regulatory (e.g., protocols, clinical study reports, key clinical submission documents) and/or public-facing (e.g., informed consent forms, clinical trial registration and results postings, plain language summaries) documents per company and evolving regulatory requirements.
• Applies advanced critical thinking, problem solving and negotiation skills to implement innovative solutions to complex challenges across the medical writing scope of work (e.g., documents, processes, tools) while navigating project team dynamics, external partnerships, collaborations, and key strategic engagements.
• Identifies and/or leads initiatives to improve medical writing processes and standards; provides expertise and/or strategic direction for use or development of MW-specific tools and technology platforms; may serve as a resource for this work internally and externally, as appropriate.
• Manages direct reports including workload, professional development, and performance management.

Requirements

• Bachelor’s degree or higher preferably in a health, scientific, or relevant discipline (e.g., life sciences, pharmacy, medicine, public health) and at least 7+ years relevant medical writing or industry experience.
• Additionally, ophthalmology experience (industry and/or academia) is required, preferably in retinal diseases, including age-related macular degeneration (AMD), retinal vein occlusion (RVO), and/or diabetic macular edema (DME).

Qualifications

• Experience independently leading, managing, overseeing, and/or authoring complex clinical regulatory (e.g., protocols, clinical study reports, key clinical submission documents) and/or public-facing (e.g., informed consent forms, clinical trial registration and results postings, plain language summaries) documents per company and evolving regulatory requirements.
• Ability to critically analyze and present clinical data clearly, objectively, and in accordance with regulatory requirements and industry guidelines.
• Strong decision-making skills. Ability to influence and drive a broader view of issues to maximize benefit and/or impact across the organization.
• Experience managing multiple, complex projects in a deadline-driven environment and leading teams of medical writers and/or cross-functional team members.
• Demonstrated critical thinking and problem-solving capabilities with an ability to innovate, influence, and drive change.
• Demonstrated effective leadership across organizational levels, including conflict resolution, negotiation, navigating teams through ambiguity, and decision making.
• Expert knowledge and thorough understanding of end-to-end drug development and clinical research and clinical trial processes.
• Ability to interpret and apply ICH guidance (e.g. GCP), global and local disclosure laws, and corporate policies.
• Excellent oral and written communication and presentation skills.
• Technical expertise in commonly used office applications (e.g., Microsoft Office Suite) and shared document systems (e.g., SharePoint) and willingness to learn and adapt to emerging technology.