Project Manager - Development

About the Department

Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple innovative modalities and therapeutic areas. Our East Coast Global Development Hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients. We recognize that improving human health starts here and that patients rely on us. We’re changing lives for a living. Are you ready to make a difference?

PURPOSE

The Project Manager supports the Project organization and Project Leads by ensuring delivery of tasks and deliverables executed according to project specifications incl. budget, timelines, and scope. This role is highly cross-functional and may involve some travel.

 

RELATIONSHIPS

Reports to the Project Vice President

 

Will interact with Finance, Human Resources, site operations, Boston Global Development leadership team on occasion.  May interact with senior leaders, on occasion.

 

ESSENTIAL FUNCTIONS

• Serve as project manager for global project teams and provide coordination, and cross-functional communication to enable teams to meet goals. This includes:
• Participating in development and subteam meetings, leading subteam meetings where needed.
• Applying program management best practices in the development, initiation, tracking, planning, execution, and control of projects.
• Performing administrative tasks including creation and maintenance of project plan documents, meeting scheduling and facilitation, and developing and tracking detailed project budgets.
• Assist Project Directors and PVPs by recording and distributing meeting agendas, minutes, and action items for project and subteam meetings; this includes follow-up on action items.
• Proactively identify and escalate risks/issues in real-time to project team and lead, enable risk-mitigation solutions to help offset risk.
• On-time escalation of noted issues to relevant team members for solving. Successfully assist in closing out escalated issues with team.
• Serve as a point of contact for coordinating timelines from subteams.
• Assist with preparation of project presentation material (eg. PowerPoint slides).
• Take ownership for updating and circulating regular project updates and work flow assignments.
• Work closely with cross functional teams to ensure ongoing communication and information flows between key stakeholders.
• Organize, coordinate and act as key driver in team documents from creation to submission.
• Maintain email distribution lists and other technology solutions to aid in team collaboration.

 

PHYSICAL REQUIREMENTS        

Ability to travel occasionally – both internationally (our headquarters are located in Denmark) and domestically in the U.S. The incumbent can work in Lexington, MA or Plainsboro, NJ.

 

QUALIFICATIONS

 

• BS degree in a science discipline.  A MS/Ph.D/MBA preferred.
• Minimum of 5+ years of hands-on related experience managing drug development projects; experience with late-stage projects a plus.           
• General knowledge of global regulatory guidance (e.g. ICH and geography-specific) a plus.     
• Experience supporting preparation of regulatory filings such as INDs, CTAs, NDAs, and briefing docu