Project Manager, Process Improvement/Clinical Development

Project Manager / Process Improvement

Business Operations Department, Clinical Development Office

Hybrid Onsite 70%/30% (Cambridge, MA, Princeton NJ or Bethesda MD)

6 Month Contract (exetension possible but not guaranteed)

We're looking for a Project Manager/Consultant (Manager/Sr. Manager Level) to work with/guide the finance & development team stakeholders to build upon and improve existing processes in order to expand study budgeting capabilities. This is a small, dynamic team that is supportive and will bring the consultant up to speed on current processes.

MUST HAVE

• Pharma/Biotech Industry Experience: In Consulting, Client Services, and/or Project Management with background in Clinical/Drug Development
• Process Improvement Experience: Experience in leading process improvement initiatives
• Stakeholder Engagement: Skilled in asking the right questions to gather information and adept at navigating and escalating issues and roadblocks
• Project Management/Multi-Stakeholder Management: Experience managing multiple stakeholders across complex work streams, with a proactive and agile communication style.

SUMMARY

PM/Consultant will be 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. Willl 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.

Responsibilities

• 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

Education & 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
• Proven track record of successful project management experience and knowledge of project management tools/software