Early Development Global Study Leader - VIE Contract

Sanofi•Morristown, NJ

About The Position

As Early Development Global Study Leader VIE within our early clinical studies team, you’ll be accountable for the proper execution and delivery of your trial for all aspects of the clinical study (end-to-end). You will implement the early development operational plan (OP) developed by the Early Development Project Leader (EDPL) for the clinical trial you have been assigned. You will also lead a cross-function team to execute the clinical study as outlined in the OP and ensure all trial deliverables are met according to study timelines, within budget, and having the highest quality standards GCP (Good Clinical Practice) /ICH (International Conference on Harmonization), Standard Operating Procedures (SOPs) and/or Quality Documents (QDs), together with the execution of the study with integrity and suitable for regulatory review. We are looking for an inspiring leader and change agent who brings new innovations and ways of working to clinical operations leveraging digitalization and AI in addition to process improvements (lean). 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. Ready to get started?

Requirements

Experience of collaborating with several internal teams.
Significant 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.
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.
Competent in digital technologies related to clinical trials and project management.
Able to continuously learn and improve as innovative technology, trends and the organization evolves.
Ability to exchange fluently (incl. negotiation), lead international meetings, write meeting minutes/ emails/ study documents, and present well in internal & external forums.
Master’s Degree in scientific discipline or equivalent is required.
Advanced knowledge of English language.

Nice To Haves

Project Management Professional certification would be a plus.

Responsibilities

Lead the Study Team on the Planning and Execution of Clinical Studies: Leads the execution of the study with integrity and suitable for regulatory review.
Organize and lead study specific meetings.
Oversee study progress with Study Team using data driven principles and ensure the training of all members of the study team.
Actively participates as needed in the Global Project Team meeting to share insights and influence as appropriate.
Organize global investigator meetings and global communications (teleconferences, news blasts, social media etc.) to the investigators.
Participate in selection of vendors, oversight of the vendors and support delivery of the service providers, if needed.
Contribute to data cleaning, RBM and data driven monitoring strategy.
Accountable for the study budget: Prepare the overall Study Budget.
Leverage support from our Global Capability Centers (Hubs) to monitor budget spending (and initial assumptions taken) during the study to make forecasts, follow expenses/ accruals, identify and evaluate complementary needs.
Work with appropriate support teams to ensure final budget reconciliation at study end.
Alert and escalate to the COPL when a deviation to the budget or budget assumptions occurs.
Ensure proper study documentation/availability.
Review study team-developed documents as per SOP, such as study id card, protocol, amendments, WSI, eCRF (Case Report Form) and completion guidelines, Centralized Monitoring Plan, committee charters and/or other operational documents as requested to provide operational input.
Preparation and oversight of study audits/inspections: Ensure preparation and proper responses to audit/inspection reports for finding associated to study management.
Develop and implement immediate action plans with study team, if needed.
Prepare and assist in PAI preparation plan with the PAI project team.
Utilize designated tools developed to oversee quality (e.g. CTMS reports, PAI Tools kit) for an Inspection-readiness approach.
Participation in cross-functional activities intended to increase efficiency and operational excellence.