Employment

Position Summary:

Establish the infrastructure for implementation of clinical protocols, collection of data and development of final reports. Oversee the direction, planning, and implementation of clinical trials and data collection. Monitor adherence to protocols and drive study completion. Hold accountability for the clinical timelines and milestones.

Location:

Boston Area

Functions:

• Provide direction in the evaluation and selection of New Molecular Entities in the formation of the portfolio
• Build and supervise clinical operations staff
• Recommend and implement process governing trials management and timelines
• Manage project planning, budget, and resource deployment for clinical studies
• Collaborate with others in design and implementation of clinical protocols, clinical data collection, and quality management
• Deliver clinical data (accountability for integrity of data systems)
• Ensure compliance with GCP and regulatory guidelines
• Oversee selection of study sites
• Manage and support investigators for studies and ensure compliance with protocol and overall clinical objectives
• Travel to field sites to supervise and coordinate clinical studies
• Ensure CMC plan aligns with business strategies
• Participate as an integral member of development team

Education:

Advanced degree preferred

Experience:

Minimum ten years experience in operational aspects of running clinical trials

Skills:

• Outstanding written and verbal communication skills
• Expert knowledge of scientific principles and concepts
• Strong leadership and management skills, excellent teamwork and collaboration skills
• Effective process and project management skills