Early Development Global Study Leader - VIE Contract

Early Development Global Study Leader - VIE Contract 

• Location: United States of America, Morristown
• Target start date: 01/08/2026

iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.

PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.

PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. Please make sure to apply with your personal email address.

About the job

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?

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main 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.

About you

Experience:

• Experience of collaborating with several internal teams.
• Significant experience in clinical operations and managing clinical studies with strong project management and project leadership skills.

Soft and technical 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. 

Education:

• Master’s Degree in scientific discipline or equivalent is required.
• Project Management Professional certification would be a plus.

Languages:

• Advanced knowledge of English language.

Why choose us?

• Be part of a pioneering biopharma company where patient insights shape drug development.
• Work at the forefront of AI-powered science that accelerates discovery and improves outcomes.
• Collaborate beyond your expertise, sparking new ideas with diverse, multidisciplinary teams.
• Help improve the lives of millions of people globally by making drug development quicker and more effective.
• Enjoy opportunities to collaborate beyond your area of expertise, working with diverse teams across science, clinical, and digital fields to spark new ideas and drive breakthroughs.
• Join a workplace where diversity, equity, and inclusion are at the core, with Employee Resource Groups and leadership programs that celebrate every voice.

iMove is a unique program tailored for European youth interested in challenging themselves with meaningful assignments across the globe. At Sanofi we have a strong ambition to invest in young talents who will drive the success of Sanofi tomorrow.

Sanofi’s Work Abroad Program, iMove, offers jobs-assignments with actual responsibilities and a perspective to grow. We provide those opportunities in various functions such as: marketing, finance, regulatory, supply chain, clinical trials, production, etc. and in more than 40 countries. Sanofi unites people who are passionate about solving healthcare needs across the world. Joining our iMove Work Abroad Program is a unique opportunity to make a difference through your work.

#LI-EUR 

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.