Incumbent will lead a team of program management professionals, key organizational growth efforts, and provide direct program leadership to some of our development programs. Independently manage and coordinate complex drug development activities for cross functional development projects, including the project management of clinical and regulatory activities. Manages strategy development, project planning, execution and delivery oversight. Works across research, development and commercial departments to establish strategy and drive execution of drug development programs. Manages project budgets, resource plans, prepares and presents status and risk management information for top management. Familiar with a variety of the field's concepts, particularly (both early and late stage) clinical and regulatory development. Relies on experience and judgment to plan and accomplish goals. A wide degree of creativity and latitude is expected.
location: Bridgewater, New Jersey
job type: Permanent
salary: $140,000 - 170,000 per year
work hours: 9 to 5
- Minimum of 7 years program / project management experience in a generic and/or new drug development environment.
- At least three years of experience as a functional leader / supervisor.
- Broad experience across the product development continuum (product, pre-clinical, clinical, regulatory development, and commercialization).
- Proficient in program management principles, practices, and tools. (PMP certification is a plus).
- Strong motivational and influencing skills. Is collaborative and inclusive. Comfortable in an agile, matrixed environment. Communicates effectively across all layers.
- Bachelor's degree, preferably advanced degree, from an accredited college/university (a degree in life sciences, engineering or medically related field is strongly preferred).
- Project Management Professional (PMP) certification is a plus
- Minimum 5 years project management experience with 5+ year's relevant experience in drug development.
- In depth knowledge and experience with drug development, particularly clinical and regulatory development. Experience with 505(2)(b) registration pathway is a plus.
- Good understanding of the overall drug development process, including its various development phases, such as pre-clinical development, clinical development, regulatory development, and commercialization.
- Proficiency in project management principles, practices, and tools is required.
- Demonstrated experience in strategic planning, project execution, control, risk and resource management for a globally networked organization is desirable
- Detailed understanding of what drives resource requirements
- Experience in successfully coordinating across several complex functions to ensure comprehensive and consistent planning and execution.
- Experience with the preparation and presentation of reports and/or presentations/communications via presentation tools such as PowerPoint, project dashboards and written reports
skills: Project Management
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.