Development Scientific Director, Ophthalmology

Sanofi•Cambridge, MA

32d

About The Position

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. 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. About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Requirements

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
Scientific expertise or interest and ability to learn in the domain of assigned study/project.
Ability to synthesize the scientific information, excellent presentation skills
Experience in drafting protocols/amendments, providing input to CSRs, regulatory documents (IBs/ INDs, Briefing books etc.)
Familiar with digital tools such as data analytics or agility to use them
Quality focused, able to develop good practices, using a critical data-driven and risk management approach
Ability to work autonomously and efficiently to provide status reports and to anticipate and escalate issues in a timely manner to execute action plans
Well organized, high level of autonomy and motivation, Good communication skills (verbal and written)
Multiple tasks handling and prioritization
Able to make proposals to manage challenging situations
Ability to work in project mode with study team and CRDs and develop trust and effectiveness
Management of priorities and workload, if involved in several projects
Ability to develop strong leadership and collaborate with cross functional team members
Team and results oriented
Experience of working internationally with Strong English skills (verbal and written if English is not the native language)
This position may require up to 15% travel
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.

Nice To Haves

Global trial experience
Clinical operations, Statistical, data management
Regulatory knowledge

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.

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