THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com
ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhances genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.
As a Program Manager you will be responsible for bringing new IVD products through the product development process. You will orchestrate and lead collaborative planning to define and execute product development processes to support the Company’s commercial business goals. This role will have responsibility for managing program timelines, identifying key risks and mitigations, and facilitating execution of program goals. As the program lead, you will interact with other departments including R&D, Marketing, Regulatory Affairs, Quality, Manufacturing, Software, Global and Regional Marketing, Customer Support and Finance to ensure that products are successfully launched, and that timelines and performance objectives are met.
Job performance will involve a variety of activities including:
- Develop integrated project management plans and project schedules using progressive elaboration
- Responsible for overall program timelines
- Manage the 'big picture' and help to initiate early on long lead items
- Receive input from subject matter experts and line function project managers
- Provide actionable insights into the Program status, progress, risks, and value
- Facilitate transparency and communication cross-functionally
- Champion best practices to ensure that the scope, business case, objectives and success metrics for projects/Programs/Portfolios are well defined, understood, measured and reported effectively
- Document key decisions and facilitate information transfer both laterally and vertically for the Program
- Facilitate efficient resource allocation within the Program
- Identify and raise project delivery issues and risks for mediation, resolution or escalation to the appropriate level on a timely basis
- Report, share and identify opportunities around Program metrics and KPIs
- Conduct project post-mortems and continuous improvement sessions
- Foster accountability of cross-functional team leads to resolve project issues and ensure project success
- Ensure that cross-functional team leads have a clear understanding of roles and responsibilities for planning and delivering project, goals, deliverables, and issues
- Support the implementation of standard project and business management processes and tools.
- 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.
- Must have experience operating at the individual project level for organizational project management.
- 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.
- 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
- 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.
- Significant 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.
- 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
- Able to organize, prioritize, and delegate tasks to efficiently move projects forward.
- BS/MS/PhD preferred with relevant training in Chemistry, Manufacturing, and/or Biological Sciences or equivalent experience.
- Project management certification (PMP®, PRINCE2®) or equivalent required.