Required Skills: 5-15 years of experience managing and leading multiple complex projects/programs within the biopharmaceutical industry, preferably as a CMC PM or combination product/device PM.
- Understands Design Control/Reviews and the five stages of device development
- Able to create a highly collaborative and inclusive environment necessary for the cross-functional device teams to be effective.
- Strong track record in executing effective program management skills in cross-functional matrix organizations.
- Excellent knowledge of program and project management discipline and its application to drug development to deliver time, cost, quality, and risk management to teams.
- Demonstrated success in creating and managing complex program plans, including experience with global teams, budgetary management, resource planning, and risk management.
- Demonstrated ability to effectively implement the tools and techniques of the program and project management discipline, such as the development and management of multi-disciplinary program level integrated plans, critical path management, project risk management, decision analysis and meeting management.
- Proven track record of achievement and delivery of team goals.
- Knowledge of clinical and commercial manufacturing and distribution issues that impact project/product strategy and planning desirable.