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Associate Director, CDO Capability Project Management
Cambridge, MA 02139
Location: Princeton, NJ; Maryland; or Cambridge/Boston, MA area
Our client is seeking a motivated and energetic Associate Director level Project Manager responsible for providing project management leadership to enable execution of cross-functional projects across clinical development. This position will play an early role in helping establishing a centralized project management function that will drive critical projects that will enable the Clinical Development Organization to scale as we look to establish key internal capabilities in support of operational excellence in our clinical trials and deliver on the promise of mRNA technology.
This role will be responsible to develop strong oversight and execution for projects and initiatives which may include developing a business case and project plan to support internal approval, as well as managing the capability build through implementation. These projects will include key partnerships across our Clinical Development (CDO) functions: Business Operations, Clinical Operations, Clinical Supply, Clinical Biomarkers, Data Management, Medical Writing, Patient Recruitment & Retention, Stats & Programing and may include Therapeutic Areas, Commercial, Finance, Regulatory, Supply Chain and more with the critical responsibility of integration across all those processes related to the projects.
The Associate Director will develop timelines, provide governance, lead certain project teams, support the functions in project planning, drive execution and manage risk, allocate budgets and resources appropriately, and coordinate interdependencies across all the functions.
The Project Manager will be involved in high-level supervision of strategic projects, with specific focus to deliver on Clinical Development capability projects:
- Direct multiple complex projects involving internal and external stakeholders and vendors
- Provide leadership to projects; be the hub of knowledge and source of truth
- Create cross functional project plans to ensure clarity of deliverables and timing
- Track, report and facilitate the resolution of issues and risks across several integrated projects
- Partner with the relevant functional leadership to drive project strategy and execution plan
- Manage project team meetings to include agenda planning, drive agenda, decision tracking and action follow-up.
- Build relationships with key stakeholders (team members and leadership) to ensure alignment of functional and corporate objectives
Requirements / Qualifications:
- BS degree in a scientific field with at least 8 years of experience or MS degree in a scientific field with 4 years of experience in a biotechnology or pharmaceutical setting
- Experience in clinical drug development
- PMP certification preferred
- Understanding and experience in GCP and/or GXP environment is preferred