Development Scientific Director, Ophthalmology

Role Summary

The Development Scientific Director (DSD) is a member of the clinical team responsible for the development and execution of clinical strategies and the clinical and operational implementation of a complex compound program. The role supports the Clinical Research Director and/or clinical lead in the medical/scientific contribution for clinical studies, from development plans and trial setup to clinical study report, in compliance with quality and regulatory processes.

Responsibilities

• Provide active scientific contribution to a cross-functional clinical team developing a molecular entity; input to the clinical development plan; work on the development of the clinical trial protocol and materials; coordinate completion of clinical study reports; support preparation of regulatory documents.
• Lead or represent clinical development across specific aspects of clinical trial execution within a matrix environment.
• Contribute to the evaluation of scientific opportunities in the therapeutic area.
• Collaborate with Coding specialists, Biostatisticians, Data Managers, Global/Regional Study Managers, Feasibility Managers, Pharmacovigilance, Medical Writers on high-quality medical scientific documents as needed.
• Ensure appropriate review and consistency of data and safety investigations with the Clinical Trial Team or Pharmacovigilance.

Qualifications

• Ophthalmology/retina clinical development, clinical trial methodology knowledge and experience required
• Leadership skills to direct and organize activities on behalf of the CRD
• Scientific expertise or strong interest with ability to learn in the assigned study/project; ability to synthesize scientific information and present it effectively
• Experience drafting protocols/amendments; providing input to CSRs and regulatory documents (IBs/INDs, Briefing books, etc.)
• Familiarity with digital tools such as data analytics
• Quality-focused with data-driven and risk-management mindset
• Ability to work autonomously, provide status reports, and escalate issues to execute action plans
• Well organized with high autonomy and motivation; strong communication (verbal and written)
• Ability to handle multiple tasks and prioritize; capable of proposing solutions to challenging situations
• Ability to work in project mode with study teams and CRDs, developing trust and effectiveness
• Ability to manage priorities and workload across multiple projects
• Strong leadership and cross-functional collaboration skills; team and results orientation
• Experience working internationally with strong English skills (verbal and written)
• Up to 15% travel may be required

Education

• Ph.D. preferred; Masters degree considered with extensive experience
• Minimum of 3 years of phase I-III clinical trial/drug development experience within ophthalmology/retina industry or CRO
• Knowledge of ICH, GCP
• Fluent in English

Skills

• Global trial experience (desirable but not essential)
• Clinical operations (desirable)
• Statistical and data management (desirable)
• Regulatory knowledge (desirable)

Additional Requirements

• Up to 15% travel may be required