Director, Clinical Development

Position Overview

The Director, Clinical Development will serve as Clinical Lead for assigned Pharmaceutical and Consumer development programs, providing strategic leadership and owning medical/scientific accountability while ensuring alignment with business goals and global regulatory requirements.

Responsibilities

• Serve as Clinical Lead on Core Teams for assigned development programs, providing strategic clinical leadership and driving program-level decisions that impact overall development success.
• Develop and drive program-level clinical development strategy aligned with target product profiles, business objectives, and regulatory pathways across global markets.
• Hold accountability for the scientific integrity, sufficiency, and quality of clinical development deliverables to meet global regulatory submission requirements.
• Own key clinical development deliverables, including protocol design, data interpretation, and risk mitigation strategies, while escalating critical matters to senior leadership as appropriate.
• Lead Clinical Evidence subteams to orchestrate strategy development and execution with cross-functional partners.
• Design and oversee clinical studies ensuring scientific rigor, regulatory compliance, and alignment with program strategy.
• Provide scientific oversight throughout study conduct, including ongoing medical/scientific data review, adjudication of major protocol deviations, and safety signal evaluation.
• When serving in Clinical Scientist capacity: author study protocols, informed consent forms, clinical study reports, and other study-level documents.
• Provide protocol training and scientific guidance to study teams.
• Represent Clinical Development in governance forums, presenting program updates, risk assessments, and strategic recommendations to senior leadership.
• Ensure all clinical activities comply with GCP, ICH guidelines, company SOPs, and applicable regulatory requirements.
• Provide clinical/scientific input into disease area strategies and portfolio prioritization decisions.
• Support business development activities through technical evaluation of potential in-licensing and partnership opportunities.
• Contribute to the development and optimization of Clinical Development processes, SOPs, and infrastructure to enhance efficiency and quality.
• Provide scientific guidance to more junior clinical development team members.

Qualifications

• Advanced degree in life sciences/healthcare in a clinically relevant area required; MD, PharmD, or PhD strongly preferred
• Minimum 5+ years of pharmaceutical/biotechnology industry and/or clinical experience with demonstrated impact in leading clinical development activities strongly preferred
• Experience in eye health/ophthalmology product development (e.g., small molecule, biologic, combination product) across a variety of ophthalmic disease states is highly preferred
• Familiarity with consumer health/OTC product development considered a plus
• Track record of successful clinical program advancement and through regulatory milestones across multiple geographic regions is preferred
• Proven experience as Clinical Lead on development programs or demonstrated readiness to assume this strategic leadership role
• Deep understanding of GCP, ICH guidelines, global regulatory requirements, and clinical development processes
• Expertise in clinical study design and working understanding of statistical methodology and data interpretation for controlled clinical trials
• Strong scientific writing skills with experience authoring regulatory documents, protocols, and clinical study reports
• Exceptional communication and presentation skills with ability to influence diverse stakeholders including senior leadership, regulatory authorities, and external experts
• Strong partnership mindset with track record of building productive relationships across R&D functions and the broader organization
• Self-motivated with ability to manage multiple priorities and drive execution with minimal supervision
• Commitment to scientific excellence, patient outcomes, and advancing eye health innovation