Director/Senior Director, Program Management
The Director / Senior Director, Program Management –is accountable for providing overall coordination and planning to cross-functional drug project teams to ensure delivery of project objectives on time and on budget. He/she will work closely with the scientific lead to contribute to and influence project strategy and tactics and will develop integrated project plans aligned with the project scope. The Project Manager will be a key interface with external providers (e.g. CROs, CMOs) for contract development, negotiation and financial management. The Project Manager effectively communicates project status and proactively identifies and resolves project risks and issues within the project team, and appropriately escalates risks or issues to senior management.
- Manage cross-functional project team for late-stage asset including providing leadership for project management activities for NDA/MAA filing in close collaboration with Regulatory Affairs
- Develop and manage cross-functional integrated project plans for NDA/MAA with input from Clinical Operations, Medical Science, Non-clinical toxicology, Microbiology, CMC, QA, Commercial, and Regulatory Affairs
- Work closely with project team and external providers to proactively identify risks and issues and develop mitigation and contingency plans.
- Communicate project progress, key issues, and risks to senior management
- Accurately forecast, report, and manage project budget in coordination with Finance
- Schedule and manage project meetings, including agendas, minutes, and action items
- As appropriate, manage/oversee US Government (USG) contract performance, monitoring, and documentation.
- Work closely with the USG on project planning and setting timelines for meeting program objectives.
- Prepare reports and deliverables associated with USG contracts, coordinating with project teams and finance department
- 12+ years of experience with a minimum of BS/BA Chemistry, Biology, Chemical Engineering or other relevant scientific discipline; or 10+ years of experience with a graduate degree in Chemistry, Biology, Chemical Engineering or other relevant scientific discipline preferred
- A minimum of 5 years of experience in pharmaceutical drug development/program management role
- PMP Certification, strongly preferred
- Experience in managing late-stage drug development projects (Phase 3 through Life Cycle Management)
- Experience developing and managing cross-functional plans (timelines, budget, resource, risk) for NDA and/or MAA submissions
- Understanding of drug development processes and milestones through all phases of development
- Ability to coordinate activities among multi-disciplinary teams comprised of internal and external parties
- Experience working with US Government Contracts and/or Grants, preferred
- Strong organizational and communication skills
- Ability to develop, execute, and manage contracts with vendors
- Strong MS-Office and MS-Project skills
- Self-starter and a team player that will thrive in a fast-paced entrepreneurial environment.
- This position is located in Malvern, PA and requires this person to be onsite. This is not a remote position.
Equal Employment Opportunity/M/F/disability/protected veteran status