Early Development Global Study Leader

Sanofi•Morristown, NJ

8h•Onsite

About The Position

The Early Development Global Study Leader (EDGSL) is the operational lead responsible for end-to-end execution and delivery of early clinical trials. They implement the operational plan developed by the Early Development Project Leader (EDPL) and ensure all trial deliverables meet timelines, budget, and quality standards (GCP/ICH, SOPs, QDs) suitable for regulatory review. The EDGSL leads a cross-functional Core Study Team including representatives from Clinical Operations, Data Management, Vendor Management, Pharmacovigilance, Clinical Research, Biostatistics, Clinical Supplies, Regulatory, Pharmacokinetics, and other relevant departments. As an inspiring leader and change agent, the EDGSL drives operational excellence while anticipating industry innovations, leveraging digitalization, AI, and process improvements (lean) to advance clinical operations. 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.

Requirements

Bachelor’s degree in scientific discipline or equivalent is required
Minimum two years of experience in clinical operations and managing clinical studies with strong project management and project leadership skills.
Solid knowledge of clinical development, GCP & ICH guidelines, regulations by major regulatory bodies such as FDA (Food and Drug Administration) and EMA (European Medicines Agency), and SOPs/ QDs.
Competent in digital technologies related to clinical trials and project management.
English language skill: ability to exchange fluently (incl. negotiation), lead international meetings, write meeting minutes/ emails/ study documents, and present well in internal & external forums.

Nice To Haves

Master’s degree (preferred).
Project Management Professional certification.
Experience of collaborating with several internal teams.
Strong ability to act as a project leader of a cross-function Clinical Study Team without direct reporting lines, thus being able to efficiently lead and collaborate in a matrixed environment.
Strong in decision making, thoughtful risk-taking and problem-solving skills.
Strong critical thinking skills; able to identify and anticipate study risks.
Agile and able to deal with frequent changes, delays or unexpected events in clinical studies.
Strong ability to lead transformation.
Excellent written and verbal communication skills.
Strong influencing skills to effectively build relationships with internal and external stakeholders.
Able to continuously learn and improve as innovative technology, trends and the organization evolves.

Responsibilities

Lead Study Planning & Execution: Drive study timelines, monitor budgets, identify quality risks, and escalate issues using data-driven principles and digital tools.
Ensure Regulatory Compliance: Execute studies with integrity suitable for regulatory review, including audit/inspection preparation and response.
Manage Cross-Functional Teams: Lead study-specific meetings, oversee team training, and coordinate with Global Project Teams and investigators.
Budget Accountability: Prepare study budgets, monitor spending with Global Capability Centers, forecast expenses, and escalate deviations to Clinical Operations Project Leader.
Document Management : Develop/review key study documents (SRMP, Monitoring Plans, protocols, eCRF) and maintain proper Trial Master File (TMF) documentation.
Vendor & Service Oversight: Participate in vendor selection, oversee service delivery, and support data cleaning and monitoring strategies
Drive Operational Excellence: Contribute to cross-functional activities focused on efficiency improvements and process innovation.