Sanofi
biopharma
DevelopmentScientificDirector
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“Development Scientific Director at Sanofi. Skills: Ophthalmology clinical trial experience, gene therapy, Program Leadership, Strategy. Drive execution of complex global clinical trials. Support Clinical Research Director”
What You'll Achieve.
Ensure delivery of high-quality data on time and within budget; Ensure achievement of corporate enrollment goals and study milestones ahead of schedule
Industry & Context.
Excellent crisis management and problem-solving abilities; Proactively identify and mitigate risks
up to 20% travel
What They're Looking For.
Must Have
Bachelor's degree, Minimum 10 years of pharmaceuticaliotech clinical development and/or clinical operations experience, Proven track record managing global Phase I-III trials from start-up through close-out, Expert knowledge of ICH-GCP, FDA regulations, and global regulatory requirements, Demonstrated proficiency in risk management, protocol development, and safety review, 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, Proven ability to lead and influence cross-functional teams in matrix environments, 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
Nice to Have
Advanced degree (MS, PhD, PharmD), Experience with audit responses and regulatory inspections
What You'll Do.
Drive execution of complex global clinical trials
Support Clinical Research Director
Contribute to clinical development plans
Develop clinical trial protocols
Coordinate completion of clinical study reports
Support preparation of regulatory filings
Provide scientific contribution to clinical team
Lead or represent clinical development
Evaluate scientific opportunities
Oversight of study execution
Ensure delivery of high-quality data
Manage study timelines
Lead program development activities
Ensure achievement of enrollment goals
Mitigate risks to maintain timelines
Collaborate with Key Opinion Leaders
Build trust with external stakeholders
Lead cross-functional team meetings
and manage clinical operations teams
Provide guidance and professional development
Participate in hiring decisions
Foster collaborative team culture
Oversee study start-up activities
Manage safety signal monitoring
Lead development of study documents
Drive process improvement initiatives
Implement and optimize clinical systems
How You'll Work.
Team & Collaboration
matrix interactions with colleagues from different disciplines; Partner with Medical, Regulatory, Quality, Clinical Supply, Data Management, and Biostatistics teams; Collaborate with Key Opinion Leaders (KOLs) and investigative sites; Build trust and credibility with external stakeholders; Lead internal and external cross-functional team meetings; Build, mentor, and manage clinical operations teams; Participate in hiring decisions and onboarding
Communication Scope
Outstanding communication and stakeholder management skills
Process & Methodology
Program Leadership, Strategy, Drive program development activities, Manage study timelines, Manage study budget, Ensure achievement of enrollment goals, Mitigate risks to maintain timelines, Oversee study start-up activities, Monitor enrollment, data quality, compliance, Lead development of study documents, Drive process improvement initiatives
Full Job Description
**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 r
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