About the Job

The Project Manager, R&D will work as part of a new product team, focused on improving blood-based cancer diagnostic capabilities in areas such as cancer detection, minimum residual disease, and other related applications. This team is comprised of talent from across the Roche ecosystem, including Roche Diagnostics, Roche Pharma and Foundation Medicine, operating as a single unit.

The Project Manager, R&D 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. Responsibilities include development and execution of project plans to deliver a defined solution business case, identification and resolution of project resource requirements and issues, and developing and managing project deliverables. The programs and products the incumbent works on spans from product concept initiation to global commercialization. This position does not have any direct reports

Key Responsibilities

• Support 2 to 3 projects depending on the stage and complexity level of the program. Projects will include research and development in assay, software, or supporting team operations and growth.
• Initiate, own and host team meetings, and support project activities while onsite or remote with the flexibility to coordinate meetings to across global time zones dependent on project and team needs.
• Develop project plans, including scope, schedule, risk, resource, and communications plans for projects.
• Build team ownership and commitment to project plans integrate cross-functional teams to ensure growth and collaboration.
• Provide structure and guidance to the team in developing plans, objectives, timelines, budgets and proposals.
• Ensure project decisions and risks are identified and prioritized. Guide the team in decision-making through analyzing options, reviewing implications, and identifying ownership.
• Elevate critical business decisions, risks or issues to the appropriate committees, management teams and/or functional managers.
• Initiate regular communication with functional leaders at set intervals on the topic of the success of projects and teams.
• Develop and track personal OKRs aligned with the department and project goals.
• Periodically mentor team members with less years of experience to contribute to and support their full potential in pursuit of project objectives.
• 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. Provide input on team and team member performance as requested.
• Monitor and ensure compliance with company policies and external regulations (e.g. state, federal or country requirements), in particular during development and launch activities.
• Other periodic projects and duties pertinent to project management as assigned.

Qualifications

Basic Qualifications:

• Bachelor’s Degree.
• 2+ years of work experience in a program or project management role.

Preferred Qualifications:

• Graduate Degree or advanced project management certification (CAPM, PgMP, PMP)
• 3+ years of experience in a program or project management role
• Proficiency in program/project management skills and principles, including scope, schedule, resource and risk management
• 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
• Effective and clear communication and presentation skills
• Demonstrated negotiation and conflict management skills
• Willingness to adapt and work in ambiguous and/or changing conditions
• Working knowledge of FDA, ISO, CLIA and CAP regulations
• Understanding of HIPAA and the importance of patient data privacy
• Commitment to reflect FMI’s values: passion, patients, innovation, and collaboration

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