Sanofi · 15 hours ago
Early Development Project Leader
Cambridge, MA
Full-time
Onsite
Entry, Mid Level
2+ years expSanofi is an innovative global healthcare company dedicated to improving people’s lives through science. The Early Development Project Leader will oversee clinical trial operations, ensuring compliance with regulations and leading cross-functional teams to contribute to drug development.
Health CareLife SciencePharmaceuticalTherapeutics
Responsibilities
Plan, execute, and finalize clinical trials operations
Develop the operation plan
Lead the cross-function study team and oversee the entire processes, including preparing protocols, recruiting subjects, collecting valuable data, managing budgets and timelines
Work with medical leads, data managers, statisticians, clinical supplies managers and regulatory affairs specialists, etc
Ensure compliance with relevant regulations, such as Good Clinical Practice (GCP) and internal SOPs
Contribute to the development of new drugs and medical devices through clinical trials
May be a core team member of the Global Project Team (GPT), representing and accountable for CSO deliverables (including preparation and attendance to TARC and DWG) in the scope of early phase development (e.g. pre-candidate to POC/POCC)
Co-Leads the JCOT (Joint Clinical Operations Team) with the Medical Lead and leads the Clinical sub-team if exists
Is Responsible and accountable for early development project deliverables
Is Responsible for optimizing the early development operational strategy, implementation and realization of FIM to POC/POCC studies based on input from all applicable functions within the CSO, in order to create the most value for the project team and the platform for operational tasks
Contribute to process improvement efforts, taking clear action to foster innovation along the value chain
Steering the program from research into global clinics, until hand off to registration and Late Development
Ensures strong relationships with sites in collaboration with CSU
Support to late stage compound, pilot and coordinate early activities : including Phase I, new POC indications and complex design studies. Be the primary point of contact for late phase development teams. Ensures smooth transition and business continuity to late development operational teams or delegates
Oversee the efforts in setting, conducting and closing clinical studies, ensuring everything runs smoothly and efficiently
Defining and monitoring budgets and schedules
Establishing guidelines
Delegating tasks
Developing strategies to optimize operations, including recruitment
Set-up accelerations
Monitor the progress of the studies, identifying risks and issues, conducting corrective measures when needed
Lead and coordinate the workforce to reach goals, all while implementing the company's policies and regulations, including the study's vision and mission, securing relationships with clinical sites and vendors
Coordinating local/countries operations
Selecting, coordinating and overseeing central vendors
Qualification
Required
US: Bachelor's Degree
2 years minimum in clinical research, preferably in clinical trial management, including an international background
Clinical Trials Management or Project Management experience required
Strong English communication skills (verbal and written) if English is a second language
Previous and strong experience in early project and clinical development from entry to development to First In Human to POC
Previous and strong experience in Dose Escalation, Dose Optimization and Dose expansion + any complex design
Familiar with all pre-clinical activities (e.g. Toxicity studies)
Leadership skills: Advanced
Risk Management skills: Advanced
Project Management skills: Advanced
Data Management skills: Basic
Scientific Background: Advanced
Clinical Development Knowledge: Advanced
Problem Solving skills: Advanced
Change Management skills: Advanced
Emotional Intelligence: Advanced
Vendor Management skills: Advanced
People Management skills: Basic
Preferred
Ophthalmology experience preferred
Field monitoring experience or related experience is an added value
Benefits
High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Company
Sanofi
Sanofi is a global biopharma company focused on prescription drugs, vaccines, and treatments for chronic, rare, and infectious diseases.
10001+ employees
H1B Sponsorship
Sanofi has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (101)
2024 (68)
2023 (59)
2022 (78)
2021 (38)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$6.97BKey Investors
Blackstone Life SciencesEvotec
2025-10-28Post Ipo Debt· $3B
2025-06-17Post Ipo Debt· $1.74B
2025-03-05Post Ipo Debt· $1.59B
Leadership Team
Paul Hudson
Chief Executive Officer
Francois-Xavier Roger
Chief Financial Officer
Recent News
2026-01-25
BioWorld Financial Watch
2026-01-25
2026-01-24
Company data provided by crunchbase