Early Development Project Leader

Job 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:

• 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. 

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: 

• oversee the efforts in setting, conducting and closing clinical studies, ensuring everything runs smoothly and efficiently.  

• defining and monitoring budgets and schedules,  

• establishing guidelines,  

• delegating tasks,  

• developing strategies to optimize operations, including recruitment 

• set-up accelerations  

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