Development Scientific Director, Ophthalmology

Role Summary

Development Scientific Director (DSD) is a member of the clinical team responsible for developing and executing clinical strategies and implementing a complex compound program. The role supports the Clinical Research Director (CRD) and/or clinical lead in medical/scientific contributions for clinical studies, from development plans and trial setup to clinical study reports, ensuring quality and regulatory compliance. Location: Morristown, NJ; Cambridge, MA.

Responsibilities

• Provide active scientific contribution to a cross-functional clinical team developing a molecular entity; input to the clinical development plan; develop the clinical trial protocol and materials; coordinate completion of clinical study reports; support preparation of relevant documents for regulatory filings.
• Lead or represent clinical development across specific aspects of clinical trial execution within a matrix of disciplines.
• May contribute to the evaluation of scientific opportunities in the therapeutic area.
• Collaborate with Coding specialist, Biostatisticians, Data Managers, Global and Regional Study Managers, Feasibility Managers, Pharmacovigilance, and Medical Writer on high-quality medical scientific documents.
• Ensure appropriate review and consistency of data and investigations of safety cases with the Clinical Trial Team 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 the scientific information; 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, able to develop good practices, using a critical data-driven and risk management approach
• Required: Ability to work autonomously and efficiently to provide status reports and to anticipate and escalate issues in a timely manner to execute action plans
• Required: Well organized, high level of autonomy and motivation
• Required: Good communication skills (verbal and written)
• Required: Multiple tasks handling and prioritization
• Required: Able to make proposals to manage challenging situations
• Required: Ability to work in project mode with study team and CRDs and develop trust and effectiveness
• Required: Management of priorities and workload, if involved in several projects
• Required: Ability to develop strong leadership and collaborate with cross functional team members
• Required: Team and results oriented
• Required: Experience of working internationally with strong English skills (verbal and written)

Skills

• 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 the scientific information; 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, able to develop good practices, using a critical data-driven and risk management approach
• Required: Ability to work autonomously and efficiently to provide status reports and to anticipate and escalate issues in a timely manner to execute action plans
• Required: Well organized, high level of autonomy and motivation
• Required: Good communication skills (verbal and written)
• Required: Multiple tasks handling and prioritization
• Required: Able to make proposals to manage challenging situations
• Required: Ability to work in project mode with study team and CRDs and develop trust and effectiveness
• Required: Management of priorities and workload, if involved in several projects
• Required: Ability to develop strong leadership and collaborate with cross functional team members
• Required: Team and results oriented
• Required: Experience of working internationally with strong English skills (verbal and written)

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 the ophthalmology/retina pharmaceutical industry or CRO is required
• Knowledge in ICH, GCP.
• Fluent in English.

Additional Requirements

• Travel: Up to 15% travel