Employment

Position Summary:

Responsible for the development and management of multiple New Molecular Entities from Candidate Selection through clinical Proof of Concept

Location:

Boston Area

Essential Functions:

• Development of key success factors for a given New Molecular Entity (NME) that gate advancement of these NME's into late phase development and commercialization
• In conjunction with the functional leadership, integration of CMC/Toxicology/Clinical/Regulatory plans in an efficient program to test key success factors
• Consultation with external experts in the formation of the program plans
• Oversight of protocol development
• With Flexion's functional leadership, selection of sites/geography to conduct trials
• In conjunction with Regulatory staff, preparation and maintenance of IND/CTA
• Oversight of the delivery of all relevant reports
• Oversight of safety and efficacy monitoring, and oversight of data management boards
• Development of program timelines and accountability for achievment of milestones

Education:

MD and/or PhD

Experience:

Greater than seven years experience in drug discovery/development with the demonstrated ability to plan and implement clinical programs/trials

Skills:

• Sufficient judgment, intellect and experience to rapidly engage in new areas of scientific/clinical endeavor
• Capacity to design concise, insightful experiments
• Process and project management skills
• Outstanding written and verbal communication skills
• Excellent collaboration skills and the ability to work interactively with small internal and external development teams