Incumbent will 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.
To provide program management leadership for 2-3 development programs transitioning into Phase 2b/3 development. Facilitate further interpretation of Proof of Concept data with the aim to finalize Phase 2b/3 development plans. Lead finalization of Phase 2b/3 plans by driving cross functional alignment and preparing for regulatory interactions. Bring program timelines and financial forecasts in line with projected full development plans. 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: Contract
salary: $85 - 90 per hour
work hours: 9 to 5
- Strong collaborative and influencing skills, and ability to work well in a cross-functional, matrixed environment
- Significant drug development experience, including in depth clinical and regulatory development experience.
- Analytical and problem-solving skills
- Strong written and oral communication skills - Meeting management / facilitation skills / teamwork and team building skills
- Ability to multi-task and manage multiple projects
- Relevant IT skills (able to work with Visio, Microsoft Project or other planning tool, PowerPoint and Excel)
- Flexible and able to adapt to company growth and evolving responsibilities
- At least 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 (PMP certification is a plus).
- 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.