Project Management / Baltimore, Maryland

Project Manager

Job Description

The Project Manager is responsible for leading, organizing and managing all aspects of product and software development projects. They are accountable to the successful delivery of project objectives, including scope, risks, budget, and timeline, through the use of an in-depth knowledge of project management methodology, tools and techniques. The Project Manager will lead, empower, and inspire large cross functional teams, and ensure internal and external stakeholder alignment throughout the project life cycle. Additionally, the Project Manager will be responsible for organizing many different moving parts, while being flexible and agile, knowing when to follow the process and when to take risks, and will successfully direct the team in response.

Key Responsibilities

  • Perform project planning to collect and align the project team and stakeholders on the project scope, timeline to completion, and budget forecasts.
  • Prepare and maintain schedules for project activities and events, taking account of dependencies, resource availability and scope.
  • Work with project representatives across functions to identify and measure risks associated with meeting budget, business metrics, timeline and scope of the project.
  • Work with department leads to identify and manage major project challenges to ensure the success of the project.
  • Create and communicate project updates in a succinct and meaningful way.
  • Monitor progress to make sure that milestones are being met across the various projects according to plan.
  • Manage the project budget including tracking expenses relative to budget.
  • Manage the project deliverables to the appropriate phase in the Stage Gate Process.

Required Education & Experience

  • 3+ years managing projects required
  • Project management in biotech, molecular diagnostics or medical device industry preferred.
  • Experience in IVDR, 510k, PMA submissions and FDA interactions preferred.
  • Experience in delivery of one or more full lifecycle product development projects recommended.
  • Knowledge of regulations and standards related to medical devices is a plus (e.g. FDA, ISO, QSR design controls).
  • Experience managing cross-functional teams is desired.
  • Excellent interpersonal skills and demonstrated ability to work with a wide variety of people at all levels of the organization within a variety of departments.
  • Problem-solving mentality with ability to adapt plans to unforeseen challenges.
  • Excellent verbal and written communication skills.
  • Must be self-driven and capable of working independently.
  • Must be able to influence and drive a team without them being direct reports.

About Personal Genome Diagnostics

Personal Genome Diagnostics (PGDx) empowers the fight against cancer by unlocking actionable information from the genome. We are committed to developing a portfolio of regulated tissue-based and liquid biopsy genomic products for laboratories worldwide. PGDx was established by internationally-recognized cancer researchers Dr. Luis Diaz and Dr. Victor Velculescu, who are pioneers in the application of innovative genomic technologies for drug development and clinical practice.

Please submit applications (cover letter and resume) to HR@​personalgenome.​com
Special consideration will be given to internal PGDx employees who apply.

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