Associate Director/ Sr Manager, Project Management - In Vitro Diagnostics

94025, Menlo Park
Jul 26, 2018
Required Education
Bachelors Degree
Position Type
Full time


We are looking for an experienced Project Management leader. The successful candidate will be responsible for managing a complex development project and work closely with the project team members representing Assay Development, Engineering, Operations, Systems Integration, Quality and Regulatory. Must work effectively in a matrix team environment to develop integrated project plans, pro-actively manage and track key project deliverables. Provide regular project team deliverables and progress updates to Senior Management. 

This position will report to the SVP, R & D.

Duties and Responsibilities:

  • Proactively facilitate and lead team discussions on project strategies, short-term and long-term project planning, opportunities for expediting timelines, identification resource constraints, and proactively identify complex project issues and risks, and assure appropriate escalation.
  • Manage Cross-Functional Project Team meetings and facilitate discussions using meeting management best practices to drive project strategy, scenario planning, cross-functional communication, timely and effective decision-making, and successful execution of program objectives. Develop agendas and summarize key meeting discussions and decisions.
  • Manage timeline and integrated project development timelines for a complex platform including consumables, reagents, assay software and instrumentation.
  • Develop, track and maintain project development timelines (integrated project plans), project deliverables and milestones; including understanding and communicating inter-dependencies and critical path activities.
  • Work closely with and build strong working relationships with cross-functional team members to develop a collaborative team environment.
  • Assist in the review of project team regulatory documents and SOP revisions, as needed.
  • Identify enhancements and development of team processes, structures, and project reporting tools.
  • May participate in audits by external certification organizations or regulatory agencies.

Position Requirements and Experience:

  • BS in a scientific field required preferably in the biological sciences or chemistry, or in engineering or the physical sciences. MS degree highly desired.
  • Experience with an excellent track record Project Management record for regulated products for IVD testing, including through product launch and post-launch support. Our ideal candidate will have both large and small company experience.
  • Minimum of 8 years of related project management experience. PMP a plus. 
  • Outstanding communication, planning and organizational skills.
  • Highly collaborative team player who fosters open communication and able to facilitate urgent needs and ability to positively influence others.
  • Proficiency related to all elements comprising a typical phase-gate process for the development and launch of commercial products.
  • Experience with projects employing Agile/Scrum methodologies. 
  • Experience with risk management for regulated products in the Medtech sector.
  • Proven ability to analyze complex activities and information to help guide decision-making that meets the overall objectives and long-range plans of projects and the organization
  •  Excellent skills to proactively predict issues and solve problems, identify risks.
  • Demonstrated success in decision-making within a multi-disciplinary, matrix team.
  • Proven record of balancing  strategic needs of the program with tactical day-to-day activities.
  • Successful track record of creating and managing accurate integrated project plans/timelines and the use of project software (Smartsheet -a cloud-based project management scheduling tool, Visio, PowerPoint and Excel, etc.).
  • This is an individual contributor role requiring finesse and a strong set of technical and people skills to influence, impact and lead the project management process for a dynamic and fast growing company in leading edge work.  Opportunities to grow the project management function for high performing, successful individuals!

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