Early Development Project Leader

J ob title : Early Development Project Leader

Location : Morristown, NJ / Cambridge, MA

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

Job purpose :

The Early Development Project Leader :

• 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

Specific to early development :

We are an innovative global healthcare company with one purpose : to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities :

The Early Development Project Leader :

About you

Education :

Experience :

Core knowledge, competencies & skills (please refer to attached file for skills assessments) :

Why Choose Us?

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; 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.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.