Director, Project Management
The Director, Project Management provides project leadership to global, cross- functional teams in the successful delivery of all phase drug development projects or sub projects within a major development program. These responsibilities include leadership of the team in predicting and planning solutions to achieve successful operational execution; driving the team to achieve clarity on issues and focus on effective contingencies; interfacing with senior management and influencing decision-making on projects. The Director, Project Management will have a high level of interaction with Senior Management to ensure that the corporate goals and project-specific development strategies are clearly integrated into cross-functional operational plans.
Responsibilities and Duties:
- Leads the project planning efforts for assigned development programs in the US and rest of world (ROW) in defining and implementation of the project strategy and operational plan by managing the creation of the operational plan and formulating the project scope, project plan, & critical paths with the Project Team and the Senior Management team. Scope of responsibilities extends from early clinical development through commercialization and post-marketing commitments.
- Identifies and drives project and resource priorities that align with the corporate goals and establishes, communicates and executes plans that drive toward established project milestones.
- Leads by example - provides clear direction and obtains buy-in of all team members to integrated, cross-functional development plan commitments.
- Ensures all alliance partners / collaborators / key vendors for whom this position is the Celldex liaison, meet Company global project deliverables and guarantees excellence of project delivery on-time and on-budget.
- Identifies ways to accelerate the project execution where possible while maintaining high quality standards.
- Develops strong logistical skills to manage activities across functions and regions.
- Prospectively identifies and escalates potential issues/risks or obstacles and either achieves resolution or plans contingencies. Follows issues through to resolution.
- Management responsibilities for various programs includes matrix management of multi-disciplinary, cross-functional team members. Provide guidance for team members and review overall progress against established timelines.
- Provides strong advocacy for a collaborative approach. Promotes leadership through collaboration, cooperation and communication across functions and between alliance/vendor partners to ensure that the team achieves stated goals.
- Responsible for setting and managing expectations, highlighting and resolving issues, ensuring regular communications and managing internal and external activities. Facilitates the system to track and monitor program objectives/goals.
- Maintains currency with appropriate regulations and guidances from FDA and other international regulatory agencies germane to our development programs to ensure proper integration with project development plans.
- Maintains currency with appropriate development advances for similar biologics/products either marketed or under development to assess impacts to our product commercialization plans.
- A BA/BS degree in science or math is required.
- An advanced degree (MS or PhD) and/or PMP certification is preferred
- Minimum of 10 years of broad drug development experience - in Clinical Research, Regulatory, CMC, or other relevant development related function.
- Minimum of 7 years experience as a project manager leading complex pharmaceutical projects in a multi-disciplinary, global environment. Extensive drug development experience with biologics in Phase I-IV is preferred.
- Minimum of 5 years people management experience and/or proven leadership experience in managing a global, matrix team.
- Proven leadership skills and strategic problem-solving ability.
- Demonstrated leadership skills managing matrix teams, influencing outcomes and key project decisions.
- Proven ability to communicate and collaborate effectively with senior management.
- Thorough knowledge of global drug development, QA/QC/Manufacturing, clinical & regulatory functions.
- Ability to read, analyze and interpret scientific and technical information and data.
- Excellent English communication skills, both verbal and written.