Development Scientific Director, Ophthalmology

Role Summary

Development Scientific Director, Ophthalmology. Location: Morristown, NJ and Cambridge, MA. The Development Scientific Director is a key member of the clinical team responsible for developing and executing clinical strategies and the clinical/operational implementation of a complex compound program. S/he supports the Clinical Research Director (CRD) and/or clinical lead in the medical/scientific contributions for clinical studies, including leading or contributing to key study documents and activities from development plans and trial setup to the 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 involves extensive cross-disciplinary interactions and the 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, s/he 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 and clinical trial methodology knowledge and experience.
• Required: Leadership skills to direct and organize activities on behalf of the CRD.
• Required: Scientific expertise or interest and ability to learn in the assigned study/project domain; ability to synthesize scientific information and present it effectively.
• Required: Experience drafting protocols/amendments and providing input to CSRs and regulatory documents (IBs/INDs, briefing books).
• Required: Familiarity with digital tools (data analytics) and ability to use them.
• Required: Quality-focused with ability to develop good practices using a data-driven and risk management approach.
• Required: Ability to work autonomously, provide status reports, and anticipate/escalate issues in a timely manner to execute action plans.
• Required: Well organized with a high level of autonomy and motivation.
• Required: Excellent verbal and written communication skills.
• Required: Ability to handle multiple tasks and prioritize effectively.
• Required: Ability to propose solutions to challenging situations.
• Required: Ability to work in a project-mode with study teams and CRDs; develop trust and effectiveness.
• Required: Ability to manage priorities and workload when involved in multiple projects.
• Required: Ability to develop strong leadership and collaborate with cross-functional teams.
• Required: Team- and results-oriented approach.
• Required: Experience working internationally with strong English skills (verbal and written).

• Preferred: Global trial experience.
• Preferred: Clinical operations experience.
• Preferred: Statistical/data management experience.
• Preferred: Regulatory knowledge.

Education

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

Additional Requirements

• Travel up to 15%.