• Job Description

  Req#: R2761923

  About the Job

  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?

  Job Purpose:

  The Global Study Leads:

  • 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

  Main Responsibilities include:

  The Global Study Leads:

  • oversee the efforts in setting, conducting and closing clinical studies, ensuring smooth and efficient execution.

  • defining and monitoring budgets and schedules,

  • establishing study guidelines,

  • delegating tasks,

  • developing strategies to optimize operations, including recruitment

  • evaluate and implement where applicable accelerations in study timelines

  • monitor the progress of the studies, identifying risks and issues, develop mitigation plans, conducting corrective measures when needed.

  • lead and coordinate the study team 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

  • manage outsourced activities or CRO if applicable

  • mentor GSLs, apprentices or trainees

  • lead/participate in transversal activities related to clinical study processes

  About you

  Education:

  • US: Bachelor's Degree

  • Europe: Master's Degree

  Experience:

  • 2 years minimum in clinical research preferably in clinical trial management, including a international background.

  • Field monitoring experience or related experience is an added value.

  • Strong English communication skills (verbal and written) if English is a second language.

  • Clinical Trials Management or Project Management experience required

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

  • Leadership skills: Intermediate

  • Risk Management skills: Intermediate

  • Project Management skills: Intermediate

  • Data Management skills: Basic

  • Scientific Background: Intermediate

  • Clinical Development Knowledge: Intermediate

  • Problem Solving skills: Intermediate

  • Change Management skills: Intermediate

  • Emotional Intelligence: Intermediate

  • Vendor Management skills: Intermediate

  Specific to early – differentiation vs late

  • 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)

  • Collaborates upfront with CSCO, Demand and Supply Leader and CMC Leader in order to secure all aspects linked to IMP (e.g: in use study anticipation, pharmacy manual, IP delivery)

  • Supports BM development in collaboration with BMOM and TMED.

  • Collaborates with main stakeholders from TMED (e.g. TMCP, PK, BCB) and CSO (e.g. ECB) during the development/definition of the FIM to POC studies.

  Why Choose Us?

  • Bring the miracles of science to life alongside a supportive, future-focused team.

  • Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

  • Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

  • Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

  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.

  #GD-SA
  #LI-SA
  #LI-Onsite
  #vhd

  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!

• About the company

  Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health.

Notice