MedFocus Dir., Proj. Mgmt - PERM in Massachusetts
The Project Manager (PM), working closely with the Global Project Leader (GPL) and the Project Medical Lead (PML), will be responsible for managing novel drug development programs to successful development, registration and market introduction. The PM will work with the GPL/PML to determine program strategies and with internal and external groups to resource and implement all aspects of a drug development project. The PM will oversee the implementation of operating plans for the program and be responsible for the overall program budget.
Provide effective leadership and direction for specific drug development programs, in conjunction with the GPL/PML and the Steering Committee.
Develop, prioritize, document and communicate measurable annual and long range plans.
Work closely with GCD, CPS/TRD and DPR/DRD like the GPL/PML, Regulatory Affairs liaison, New Products Planning, CMC, Clinical Operations, and Biostatistic representatives to set team strategies through the Steering Committee.
Manage and lead the Program Team Meetings.
Attend key meetings with regulatory agencies.
Serve as cost center manager for the entire drug development program.
Working with the GPL/PML, ensure that management is appraised, in a timely fashion, of the current status and issues surrounding each project, and communicate these with appropriate governance bodies for local and global projects.
Serve as PM on one or more local or Global Program Teams, providing a model for effective team leadership.
Manage the Program through effective budget planning and accountability, objective setting, performance appraisal and individual development, as appropriate.
Review and allocate resources in collaboration with functional areas and project teams.
10 years solid scientific background in pharmaceutical drug development with at least 5 years of experience in a program management or Team leadership function.
Have a past record of achievement in leading and managing programs and product development with a thorough understanding of the drug development process at a strategic level.
Track record of success leading project teams toward NDA/ MAA submissions.
Have an experience in a budget management of projects/functions.
Strong knowledge of program budget process and resource allocation
Min Salary: $0.00
Max Salary: $0.00