Development Scientific Director, Ophthalmology

Role Summary

The Development Scientific Director (DSD) is a clinical team member responsible for developing and executing clinical strategies and implementing complex compound programs clinically and operationally. The role supports the Clinical Research Director and/or clinical lead in medical/scientific contributions for clinical studies, from development plans and trial setup to clinical study reports 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, development of the clinical trial protocol and materials, coordinate completion of clinical study reports, and support preparation of regulatory documents.
• Lead or represent clinical development across specific aspects of clinical trial execution with extensive cross-disciplinary matrix interactions.
• Contribute to the evaluation of scientific opportunities within the therapeutic area.
• Collaborate with Coding specialists, Biostatisticians, Data Managers, Global/Regional Study Managers, Feasibility Managers, Pharmacovigilance, and Medical Writers on high-quality medical scientific documents as needed.
• Ensure review and consistency of data and investigations of safety cases with the Clinical Trial Team or Pharmacovigilance.

Qualifications

• Required: Ophthalmology/retina clinical development experience and clinical trial methodology knowledge; leadership skills to guide activities on behalf of the CRD; ability to synthesize scientific information and present it effectively; experience drafting protocols/amendments and providing input to CSRs and regulatory documents (IBs/INDs, briefing books); familiarity with data analytics or digital tools; quality-focused with data-driven, risk-based approach; ability to work autonomously, provide status reports, and escalate issues as needed; strong organizational skills and motivation; excellent verbal and written communication; ability to manage multiple tasks and prioritize; ability to work in a project-mode with study teams and CRDs; strong leadership and collaboration across cross-functional teams; team and results orientation; international experience with strong English skills; travel up to 15%.
• Required: Ph.D. preferred; Masters degree considered with extensive experience; minimum 3 years of phase I-III clinical trial/drug development experience in ophthalmology/retina industry or CRO; knowledge of ICH/GCP; fluent in English.

Education

• Ph.D. preferred; Masters degree considered for candidates with extensive experience.
• A 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

• Clinical development leadership
• Scientific writing and regulatory documentation
• Cross-functional collaboration and stakeholder management
• Data interpretation and risk management
• Strong communication and presentation skills

Additional Requirements

• Travel up to 15% may be required.