Development Scientific Director

Sanofi•Cambridge, MA

4d•Hybrid

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. 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.

Requirements

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
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
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

Nice To Haves

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

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