Early Development Project Leader

Role Summary

Early Development Project Leader

Responsibilities

• 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, to create 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
• Ensure 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. Ensure 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 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

Main Responsibilities

• 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
• Monitor the progress of the studies, identifying risks and issues, conducting corrective measures when needed
• Lead and coordinate the workforce to reach goals, ensuring compliance with company policies and regulations, securing relationships with clinical sites and vendors
• Coordinating local/countries operations
• Selecting, coordinating and overseeing central vendors

Education

• US: Bachelor's Degree

Experience

• 2 years minimum in clinical research, preferably in clinical trial management, including an 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
• Ophthalmology experience preferred

Skills

• Leadership skills: Advanced
• Risk Management skills: Advanced
• Project Management skills: Advanced
• Data Management skills: Basic
• Scientific Background: Advanced
• Clinical Development Knowledge: Advanced
• Problem Solving skills: Advanced
• Change Management skills: Advanced
• Emotional Intelligence: Advanced
• Vendor Management skills: Advanced
• People Management skills: Basic