Project Manager - Diagnostic Strategy (ADX-33-21) at ArcherDX
In October 2020, Invitae Corporation (NYSE: NVTA) combined with ArcherDX, a genomic analysis company specializing in cancer diagnostics and monitoring, to create a leading comprehensive medical and cancer genetics company. As a combined company, Invitae, is bringing world-class genetic testing and diagnostics into mainstream medicine to improve healthcare for billions of people. Our goal is to aggregate the world’s genetic tests into a single service with higher quality and accuracy, faster turnaround time and actionable results. Learn more at invitae.com and archerdx.com.
The Diagnostic Strategy Project Manager will identify, organize and drive key initiatives within the broad Diagnostic Strategy organization of Archer which includes the following departments: Market Access, Regulatory Affairs, Quality, Clinical Services, Manufacturing, Engineering, and Strategic Operations . This role will help enable best-in-class performance by tracking key deliverables, communicating priorities and anticipating obstacles. This position will complement the broad Diagnostic Strategy organization with sharp organizational communication, planning, and transparency.
- Organize and drive execution of key initiatives
- Assist leaders by creating detailed project plans for tracking critical workstreams, milestones and deliverables
- Standardize communications within the department, providing regular status and progress updates to senior management and core teams
- Strategize with program and senior management for the balancing of competing priorities, challenging timelines, and resource deployment
- Assist with strategic operations, scheduling and throughput planning
- Identify areas for improvement in operations and deploy strategies that drive improvement
- Collaborate closely with the Program Managers to ensure project managers possess accurate information on deliverables and initiatives
- Create dashboards for management review and external partners
- Be a visible proponent of quality culture within Archer
- Provide strategic insight throughout the product development process and ensure strong domain representation in product development and manufacturing services teams
- Support investigations of laboratory and product issues to insure timely, closed loop corrective actions and reports as required
- Track and measuring progress and identify and manage project risk
- Lead execution of ECO/ECR process for assigned projects for ECCB review and approval
- Drive and determination
- Ability to work in a fast paced and dynamic environment.
- Understanding of design controls and diagnostic approval process from concept to submission.
- High energy, 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.
- Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company.
- Strong communication and presentation skills
- Driven to perform
- Self-directed: needs little explicit direction
- Ability to organize, prioritize, and delegate tasks to efficiently move projects forward.
- For those project managers assigned to Clinical initiatives:
- Experience with clinical trials within a biotechnology, pharmaceutical or biopharmaceutical company
- Demonstrated ability to design and develop products and to interpret and evaluate clinical data
- Minimum of 5 years' Program/Project Management experience in the diagnostic or pharmaceutical industry.
- Proven ability to coordinate multifaceted projects, including multitasking, deliverables management and timeline management.
- Demonstrated ability to work within a commercial environment and influence with and without authority in a cross functional role.
- PMP certification strongly preferred
- Working knowledge of cGMP/CFR/ISO standards & FDA regulations preferred
- Bachelor's degree in a technical discipline