Early Development Project Leader

Job Title:

Early Development Project Leader

Location:

Morristown, NJ

The Early Development Project Leader provides strategic input into the early global development plan as well as directs, supervises and manages all operational aspects of global clinical early projects (e.g. pre-candidate to POC/POCC) and is accountable for ensuring quality deliverables on time and within budget.

The Early Development Project Leader is a core member of the Global Project Team (GPT) and co-manages the Clinical Sub-Team (CST) (or the Joint Clinical Operations Team (JCOT) if applicable).

The Early Development Project Leader is expected to be able to effectively lead several early complicated program developments with minimal guidance.

The Early Development Project Leader is the main partner between the global project team and the larger operations group and manages project deliverables on a day-to-day basis.

The Early Development Project Leader is accountable for ensuring deliverables through effective program/project management, using his/her business acumen and people skills to lead programs in an effective and agile manner.

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? Early Development Project Leader is considered to be a very experienced Project Leader, able to work independently and manage several early programs at different stages.

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.

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.

• Operational strategy & execution:
  Responsible for providing input into the early operational strategy, prepares operational assumptions at project level to support development of global study budgets, and accountable for development of operational plans, with input from all applicable functions within the CSO, in order to propose the optimal early clinical operations solutions and scopes of work that creates the most value for the project and company.
• Accountable for ensuring the study/program performance within the CSO and for driving the multi-disciplinary CSO project team according to project requirements & defined project objectives to create the most value for the project.
• Represents CSO when collaborating and goal setting with other functions and across projects, enabling functions to successfully meet the requirements, milestones, and deliverables of the clinical development plan as defined by the GPT.
• Contribute to CSO business expansion and innovation.
• Identify opportunities for improving organizational processes to continue to drive organizational and operational excellence.
• Specific to early development:
  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 TMU (e.g. ECET, PK, BCB), TA and CSO (e.g. ECB) during the development/definition of the FIM to POC studies.
• Responsible for optimizing the early development operational strategy, implementation and realization of FIH to POC/POCC…