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Associate Director, CDO Capability Project Management

Cambridge, MA 02139

Posted: 04/04/2022 Employment Type: Direct Hire Job Category: Clinical: R&D Program Management Job Number: 3137

Job Description


Location: Princeton, NJ;  Maryland; or the  Cambridge/Boston area

This position will be located in Cambridge, MA. Our client  is seeking a motivated and energetic Associate Director level Project Manager responsible for providing project management to enable execution of cross-functional projects across clinical development.

This position will help establish a centralized project management function that is responsible to drive critical projects that enable Clinical Development Operations 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 their assigned projects and initiatives which may include developing a business case and project plan to support internal approval, as well as managing the capability build plans through implementation and change management. These projects will include key partnerships across our Clinical Development (CDO) functions: Clinical Trial Excellence, Clinical Operations, Clinical Supply, Clinical Biomarkers, Data Management, Medical Writing, Patient & Site Experience, Stats & Programing and may include Therapeutic Areas, Commercial, Finance, Regulatory and more with the critical responsibility of integration across all those processes related to their projects.

The Associate Director will develop timelines, support required governance, drive their project teams and workstreams in project planning, execution, management of risk, and allocation of budgets as required. They will work to coordinate interdependencies of their assigned projects amongst other critical projects support by the Capability Project Management team.

Specific initial focus will be on supporting establishment of our Clinical Content Environment to include building and implementing a structured content authoring system in partnership with Digital to include a clinical content library, authoring & review collaboration capabilities, utilization of standardized text documents as well as implementation of AI and machine learning to enhance our processes.


Responsibilities:

The Project Manager will be involved in high-level supervision of strategic projects, with specific focus to deliver on Clinical Development capability projects:
  • Initial focus on supporting establishment of our Clinical Content Environment
  • Direct multiple complex workstreams and 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 6 years of experience in a biotechnology or pharmaceutical setting
  • Experience in clinical drug development; Experience in medical writing, clinical operation or regulatory is strongly preferred.
  • PMP certification preferred
  • Understanding and experience in GCP and/or GXP environment is preferred
  • Proven track record of successful project management experience and knowledge of project management tools/software
  • Demonstrated experience in leading cross-functional programs in business setting, consulting setting and preferred in established development organization
  • Must be adept at working in a fluid environment and foster a strong collaborative spirit internally and externally.
  • Strong personal skills to influence without authority, motivate others and manage conflict.
  • Strong written and oral communication skills as well as demonstrated organizational aptitude
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