About the Job

The Senior Project Manager, Early Detection is responsible for the planning and execution of new biopharma clinical product development projects and/or lab expansion projects, as well as other business critical initiatives. The role generates and executes a project plan to deliver the defined solution business case, as well as identifies and resolves resource requirements and issues pertaining to the designated project. The position develops and manages project deliverables, and the programs and products worked by the incumbent may span from product concept initiation to global commercialization.

Key Responsibilities

• Project Management:
  • The Project Manager will support 2 to 3 projects depending on the stage and complexity level of the program. Projects will include research and development in assay, software, and supporting team operations and growth.
  • Independently creates and manages project scope, schedule, and resource plans.
  • Ensure project resources are planned, committed, and communicated. Resolves conflicts and obtains cross-functional team buy-in and ownership to meet the objectives.
  • Build team ownership and commitment to project plans and integrate cross-functional teams to ensure growth and collaboration.
  • Provide structured thinking to project team on overall approach and delegate tasks as appropriate.
  • Facilitate project risk and issue management. Ensure project decisions and risks are identified, prioritized, and elevated as needed. Guide the team in decision-making through analyzing options and reviewing implications. Make decisions pertinent to the project as needed.

• Communications and Reviews:
  • The PM is expected to support project activities while onsite or remote with the flexibility to coordinate meetings to enable global time zone interactions dependent on project and team needs.
  • Presents project goals and progress effectively to internal project stakeholders and department management.
  • Define, track and make visible key project metrics. Create project status reports or dashboards.
  • Act as liaison to senior management and project/portfolio committee for communication, project presentations and phase gate reviews.
  • Elevate decisions to the appropriate committees, management teams or functional managers.
  • Develop and present budget and resource plans for organizational reviews.

• Relationship Management:
  • Provide input to functional leaders on team and team member performance.
  • Develop and maintain strong relationships with functional leaders to drive success of projects and teams.
  • Engage cross-functional leaders and stakeholders to drive decisions, clarity, and collaboration, to achieve optimal project outcomes.

• Process Management:
  • Facilitate the success of the team in multiple phases from research and early ideation to product development through to launch.
  • Leverage knowledge and quality system use in project or product creation and continued compliance.
  • Actively apply best practices pertinent to designated project tasks and phases to ensure functional excellence of the team and delivery of solutions. Implement improvements on an as needed basis.
  • Drive efforts to ensure cross-functional groups and systems effectiveness.

• Team Management:
  • Lead 2-3 teams of cross-functional representatives in the achievement of organizational goals.
  • Influence in a complex, matrixed environment, for optimal project outcomes.
  • Foster a team environment that enables all participants to contribute their full potential in pursuit of project objectives.
  • Monitor and ensure compliance with company policies and procedures (e.g., federal/country, and regulatory requirements).

• Other duties as assigned.

Qualifications

Basic Qualifications

• Minimum of bachelor's degree (any field, science or engineering preferred).

• 5+ years of project management experience within the biotechnology or life sciences industry

Preferred Qualifications

• Project manager with 5+ years’ experience managing assay development, software projects in life science, CDx, or oncology preferred

• PMP or CAPM preferred

• Proficiency in project management skills and principles contributing to project management best practices and process improvements

• Software, IT and infrastructure support project experience

• Experience with waterfall and/or Agile (Scaled) practice, methodologies, or certification

• Prior experience:
  • Working with culturally diverse and geographically distributed teams virtually and on-site
  • Proficiency in project management tools e.g., Smartsheet, Microsoft, JIRA, Trello etc.
  • Demonstrated end to end development activities working within deadlines and resource constraints. Managing program scope, roles and responsibilities, specifications, timelines, and resources in a highly independent position
  • Familiarity with regulated products, regulatory and quality management standards and systems (FDA, ISO, IEC, CAP, CLIA)
  • Coordinating program details across disciplines and integrating all aspects of the business as they impact development projects

• Clear and effective communication and presentation for executive leadership and across teams

• Demonstrated negotiation and conflict management skills

• Understanding of HIPAA and the importance of patient data privacy

• Commitment to reflect FMI’s values: passion, patients, innovation, and collaboration