Development Scientific Director, Ophthalmology

Job Title: Development Scientific Director

Location: Morristown, NJ Cambridge, MA

About the Job

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.

Main 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.

About You

Knowledge And 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

• 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

Formal Education And/Or Experience Required:

• 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.

Knowledge And Skills Desirable But Not Essential:

• Global trial experience

• Clinical operations,

• Statistical, data management

• Regulatory knowledge

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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