Project Manager - Diagnostics (330-20)

POSITION SUMMARY:

The Project Manager will provide project management leadership and expertise to enable the organization to meet business objectives. This individual will manage one or more projects and apply project management knowledge, skills, tools, and techniques to project activities to meet project requirements and achieve desired outcomes. The selected candidate will lead projects throughout the entire lifecycle of initiation, planning, execution, monitoring & control, and closing under the leadership directive of Diagnostics & Clinical Development Program Management. The Project Manager will engage subject matter experts and functional leaders to develop integrated project plans, identify stakeholder requirements, and balance competing project constraints of scope, quality, schedule, budget, resources, and risk.

RESPONSIBILITIES:

• Ensure projects are delivered on time and risks associated with timelines/deliverables clearly communicated to management.
• Develop integrated project management plans and project schedules through the use of progressive elaboration
• Document key project decisions and facilitate information management processes
• Prioritize team and physical resource allocations.
• Implement processes to manage and control all types of project change
• Lead project team meetings, develop agendas, follow-up on action items
• Address the needs, concerns, and expectations of all stakeholders through active and collaborative communication
• Effective verbal and written communication with internal and external stakeholders including clients and regulators.
• Willingness to travel up to 10% of the time.
• Support project teams through the initiation, planning, execution, monitoring/control, and closing of their projects by providing sound project management expertise and coaching.
• Facilitate issue and risk management in collaboration with the project/program teams.
• Support the implementation of standard project and business management processes and tools. These processes and tools may include the development, monitor, and control of integrated timelines, budgets, risk management plans, communication plans, and business process maps.
• Generate or integrate project specific metrics/reports and analyzing options and opportunities to optimize the project team’s productivity.
• Collect data for and prepare accurate management of governance committee updates on project status using appropriate templates and tools.
• Establish, maintain and use information repositories and collaboration sites.
• Identify and mitigate project risks.
• Must have demonstrated knowledge of project management skills, tools, and processes in areas such as timeline, cost, and risk management.
• Proficiency with standard project management software and enterprise resourcing planning.
• Effectively communicate project status to external pharma partners throughout the development process
• Bring forth solutions to meet timelines when at risk. Including manufacturing, software, regulatory, assay development, validation, etc.
• Review, understanding, and compliance with ArcherDX HIPAA Security policies and procedures.
• Safeguarding the privacy and security of protected health information and European Union personal data.
• Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology
• Review, understanding, and compliance with ArcherDX HIPAA Security policies and procedures.
• Safeguarding the privacy and security of protected health information and European Union personal data.
• Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology.

EXPERIENCE:

• BS/MS/PhD preferred with relevant training in Chemistry, Manufacturing, and/or Biological Sciences, or equivalent experience.
• 5 years' experience in the diagnostic or pharmaceutical industry.
• Familiar with biostatistical processes and infrastructure.
• Experience with LIMS, analytical reporting and/or working with genomic data.
• Project management certification (PMP®, PRINCE2®) or equivalent.
• Experience with design control for medical device development.
• Understanding on 510k and PMA diagnostic approval process from concept to submission.
• Understanding of clinical trial logistics and brining drug and diagnostic from concept to approval.
• Significant experience with clinical trials within a biotechnology, pharmaceutical or biopharmaceutical company.
• Experience operating at the individual project level for organizational project management.

Additional Skills:

• Self-motivated, approachable and articulate team player.
• Demonstrates strong leadership capabilities with the ability to lead a cross-functional team (assay development, laboratory, clinical, software, etc.) through a complex development program.
• Demonstrated ability to design and develop products and to interpret and evaluate clinical data.
• The ability to forge strong internal and external partnerships coupled with excellent presentation, communication and interpersonal skills.
• Excellent oral and written communication skills.
• Strong interpersonal, team working, and leadership skills.
• Strong attention to detail demonstrating accuracy in tracking and reporting data.
• Good problem-solving skills; able to anticipate and recognize problems, diagnose root causes and take corrective action to prevent recurrence.
• Independent self-management and organizational skills; able to manage workload, set personal and project priorities and adjust as needed.
• Flexibility to adjust quickly and effectively to frequent change and altered priorities.
• Excellent work planning and execution/delivery skills – includes problem solving, prioritization, and task-level influence skills.
• Ability to influence without power.
• Strong ability to communicate both at a detailed (e.g. task status, task management, task execution) level and management through executive level (e.g., high level summary verbal and written to sponsors of the planning and execution status).
• Proven ability to coordinate multifaceted projects, including multitasking, deliverables management and timeline management.
• Demonstrate ability to work within a commercial environment and influence with and without authority in a cross functional role.
• Experience in diagnostic development or similar development paradigm.