Job Title:
Early Development Project Leader
Location:
Cambridge, Massachusetts
Morristown, New Jersey
Salary Range:
USD 147,000.00 – 212,333.33
At a Glance:
Join a team where deep immunoscience meets cutting-edge innovation. Across oncology, rare diseases, neurology, and vaccines, you’ll work at the intersection of lab science and AI-powered discovery. Collaborate across boundaries to turn breakthrough ideas into real-world impact, while deepening scientific expertise or developing as a leader.
About the Job:
Are you ready to shape the future of medicine? At Sanofi, we accelerate drug discovery and development to deliver solutions faster to patients and families.
The Early Development Project Leader (EDPL) plays a pivotal role in planning and executing early-phase clinical trials, ensuring compliance, operational excellence, and cross-functional collaboration.
Key Responsibilities:
Clinical Trial Operations & Strategy
Plan, execute, and finalize early development clinical trials (FIM to POC/POCC).
Develop operational plans, protocols, recruitment strategies, and study designs.
Lead cross-functional study teams (medical leads, data managers, statisticians, supplies, regulatory).
Ensure compliance with GCP and internal SOPs.
Optimize strategies for dose escalation, dose optimization, and complex study designs.
Project & Team Leadership
Co-lead JCOT (Joint Clinical Operations Team) with Medical Lead.
Represent CSO deliverables in Global Project Teams (GPTs).
Drive process improvement, innovation, and operational efficiencies.
Serve as primary contact for late-phase development teams ensuring smooth transitions.
Vendor & Site Management
Build and maintain strong site relationships in collaboration with CSU.
Select, coordinate, and oversee central vendors.
Secure IMP supply in collaboration with CSCO, CMC, and Demand & Supply leaders.
Specialized Early Development Expertise
Strong background in early-stage clinical development from entry to First-in-Human to Proof of Concept.
Familiar with preclinical activities (e.g., toxicity studies).
Collaborate with biomarkers and translational medicine stakeholders.
Operational Excellence
Monitor budgets, timelines, and study progress.
Identify risks/issues and implement corrective measures.
Ensure business continuity and compliance with company vision, mission, and regulations.
About You:
Education
Bachelor’s degree required (advanced degree preferred).
Experience
Minimum 2 years in clinical research/clinical trial management.
International background or field monitoring experience is an advantage.
Experience in ophthalmology is preferred.
Core Knowledge & Skills
Leadership, Risk Management, Project Management: Advanced
Clinical Development & Scientific Knowledge: Advanced
Problem Solving, Change Management, Emotional Intelligence: Advanced
Vendor Management: Advanced
Data Management & People Management: Basic
Strong English communication skills (verbal and written).
Why Choose Us?
Work alongside a supportive, future-focused team bringing science to life.
Endless opportunities for career growth (promotions, lateral moves, international roles).
Competitive, well-crafted rewards package.
Comprehensive health and wellbeing benefits, including high-quality healthcare, prevention programs, and at least 14 weeks of gender-neutral parental leave.
Diversity & Inclusion:
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers. All qualified applicants will receive consideration regardless of race, color, creed, religion, sex, national origin, age, gender identity, marital status, sexual orientation, disability, veteran status, or other characteristics protected by law.
Tagline:
Pursue Progress. Discover Extraordinary.
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