Development Scientific Director, Ophthalmology

Role Summary

The Development Scientific Director (DSD) is a responsible member of the clinical team dedicated to the development and execution of clinical strategies and the clinical and operational implementation of a complex compound program. The primary purpose of the development scientific director’s position is to support the Clinical Research Director (CRD) and/or clinical lead in the medical/scientific contribution for the clinical studies on activities pertaining to the Study Medical Manager (SMM) responsibilities e.g.: leading or contributing to key study documents and activities from clinical development plans and trial set-up to clinical study report in compliance with quality and regulatory processes.

Responsibilities

• Development scientific director provides active scientific contribution to a cross-functional clinical team developing a molecular entity, provide input to the clinical development plan, work on the development of the clinical trial protocol, clinical trial materials, and take responsibility for coordinating completion of clinical study reports and support preparation of relevant documents for regulatory filings.
• This role will involve extensive team matrix interactions with colleagues from a number of different disciplines and development scientist is responsible for leading or representing clinical development across specific aspects of clinical trial execution.
• This individual may be asked to contribute to the evaluation of scientific opportunities in the therapeutic area.
• Under the guidance of his/her manager in the Therapeutic Area department, he/she collaborates with the Coding specialist, Biostatisticians, Data Managers, Global and Regional Study Managers, Feasibility Managers, Pharmacovigilance representative, Medical Writer (e.g. planning and review of narratives) on high quality medical scientific documents, as needed.
• He/she ensures appropriate review and consistency of the data and investigations of safety cases with the Clinical Trial Team (Monitoring Teams) or Pharmacovigilance.

Qualifications

• Required: Ophthalmology/retina clinical development, clinical trial methodology knowledge and experience.
• Required: Leadership skills to give directions and organize the activities on behalf of the CRD.
• Required: Scientific expertise or interest and ability to learn in the domain of assigned study/project; ability to synthesize scientific information and excellent presentation skills.
• Required: Experience in drafting protocols/amendments, providing input to CSRs, regulatory documents (IBs/INDs, Briefing books, etc.).
• Required: Familiar with digital tools such as data analytics or agility to use them.
• Required: Quality-focused with a data-driven and risk management approach.
• Required: Ability to work autonomously, provide status reports, and escalate issues to execute action plans.
• Required: Well organized with high autonomy and motivation.
• Required: Good communication skills (verbal and written).
• Required: Multi-tasking and prioritization abilities.
• Required: Able to propose solutions to challenging situations; able to work in a project mode with study teams and CRDs and develop trust/effectiveness.
• Required: Management of priorities and workload when involved in several projects; strong leadership and cross-functional collaboration.
• Required: Team and results oriented; experience of working internationally with strong English skills (verbal and written if English is not native).
• Required: Up to 15% travel may be required.

Education

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

Skills

• Ophthalmology/retina clinical development
• Clinical trial methodology
• Strategic leadership and cross-functional collaboration
• Scientific synthesis and presentation
• Regulatory documentation (IBs/INDs, CSRs, briefing books)
• Data analytics familiarity
• Quality management and risk assessment
• Independent work cadence with proactive communication
• Project management in multi-site, international contexts
• Strong written and verbal communication in English

Additional Requirements

• Travel up to 15% may be required.