Development Scientific Director

Job title: Development Scientific Director

Location: Cambridge, MA / Morristown, NJ / Washington, DC

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.

We are seeking an accomplished Development Scientist Director with deep expertise in ophthalmology and gene therapy programs to drive the execution of complex global clinical trials. He/she 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 Scientist 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.

It is expected the Development Scientist 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 and amendments, 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.

This role will also serve as a strategic lead responsible for end-to-end study oversight, from feasibility through study close-out, ensuring delivery of high-quality data on time and within budget.

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

Therapeutic Expertise

• Required: Ophthalmology clinical trial experience including gene therapy (retinal diseases, nAMD, geographic atrophy, etc.)
• Experience with first-in-class compounds and novel therapeutic modalities
  
  

Program Leadership & Strategy

• Leadership skills to give direction, organize activities and Progress deliverables on behalf of the clinical research director (CRD)
• Serve as the development representation for strategy and execution for global Phase I-III ophthalmology clinical programs, including gene therapy and novel therapeutic modalities
• Serve as a primary development point of contact for CROs, vendors, investigative sites, KOLs, and internal cross-functional teams
• Drive program development activities including feasibility, site selection, start-up, enrollment strategies, and study timelines
• Ensure achievement of corporate enrollment goals and study milestones ahead of schedule
• Proactively identify and mitigate risks to maintain program timelines and quality standards
  
  

Cross-Functional Collaboration

• Partner with Medical, Regulatory, Quality, Clinical Supply, Data Management, and Biostatistics teams to ensure seamless study execution
• Collaborate with Key Opinion Leaders (KOLs) and investigative sites to develop protocols, training materials, and operational strategies
• Build trust and credibility with external stakeholders to strengthen company brand and investigator relationships
• Lead internal and external cross-functional team meetings to drive alignment and decision-making
  
  

Team Leadership & Development

• Build, mentor, and manage clinical operations teams including Clinical Project Managers, CTAs, and CRAs
• Provide guidance and professional development to direct reports
• Participate in hiring decisions and onboarding of new team members
• Foster a collaborative, high-performance team culture
  
  

Study Execution Excellence

• Oversee study start-up activities including site activation, regulatory submissions, and training delivery
• Monitor enrollment, data quality, and protocol compliance across global sites
• Manage safety signal monitoring and coordinate with Medical Monitors to ensure subject safety
• Lead development of study documents including study plans, ICFs, training materials, SOPs, and CSRs
• Ensure GCP, regulatory, and SOPs compliance across all study activities
• Drive process improvement initiatives and contribute to departmental SOP development
  
  

Systems & Technology

• Collaborate with stakeholders to implement and optimize clinical systems (IRT, EDC, CTMS, ePRO)
• Oversee system UAT, training, and issue resolution
  
  

About You

Required Education & Experience:

• Bachelor's degree
• Minimum 10 years of pharmaceutical/biotech clinical development and/or clinical operations experience
• Proven track record managing global Phase I-III trials from start-up through close-out
  
  

Technical Skills

• Expert knowledge of ICH-GCP, FDA regulations, and global regulatory requirements
• Demonstrated proficiency in risk management, protocol development, and safety review
• Strong budget development and financial management capabilities
• Experience with both in-sourced and fully outsourced (FSP/CRO) trial models
• Proficiency with clinical trial management systems and technologies
  
  

Leadership Competencies

• Proven ability to lead and influence cross-functional teams in matrix environments
• Strong vendor and cross-functional management skills with demonstrated ability to drive accountability
• Excellent crisis management and problem-solving abilities
• Strategic thinker with ability to balance short-term challenges and long-term program goals
• Outstanding communication and stakeholder management skills
  
  

Preferred Qualifications

• Advanced degree (MS, PhD, PharmD) preferred
• Experience with audit responses and regulatory inspections
  
  

Travel

• This position may require up to 20% travel
  
  

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 US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.