Director - IVD/CDx Assay Development (ADX-211-19)
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 enhance 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.
Residing in our Boulder, CO office, the Director- IVD/CDx Assay Development is key member of a rapidly growing IVD and Companion Diagnostics product development team in leading a group responsible for developing and optimizing one or more IVD assays using cutting-edge NGS technology. Will be responsible for developing, execution, and critical evaluation of experimental designs in support of clinically geared projects leading to the FDA submission.
Will work closely with R&D, Quality, Regulatory, Clinical, and Production teams to translate laboratory processes from feasibility to validated assay. Additionally, they will work closely with the Marketing, Clinical, and Quality Teams on document drafting, revising, and approval. The successful candidate will have strong leadership and multi-discipline skills from technical, to writing, to communication.
- Coordinate and oversee the full implementation and execution of programs with external and internal collaborators within the accepted timelines, budgets and resources
- Drive the overall product development planning and implementation strategy for Companion Diagnostics product(s)
- Oversee verification and validation protocols and study execution under Design Control
- Oversee the study data analysis and study reports writing
- Participate in cross-functional teams (including bioinformatics, software, clinical development, manufacturing, quality and regulatory)
- Participate in the planning, writing and implementation of laboratory focused clinical trials and collaborative studies.
- Serve as a liaison to Technical, Clinical Development & Operations for clinical biomarker validation activities
- Draft technical regulatory documents for CDx applications for regulatory approval
- Develop status reports for Executive Team and external collaborators
- Publish scientific results
- MS/PhD in biology, molecular biology, biochemistry or related field
- Minimum of 15 years' experience in the diagnostic or pharmaceutical industry
- Strong experience with design control, verification and validation of FDA-regulated products
- Proficiency in NGS, PCR, qPCR, and sample prep techniques
- Experience writing protocols, reports, pre-submissions, IDE and other PMA submission related documentation for molecular diagnostic applications
- Knowledge of principles of quality control and quality assurance
- Proven ability to coordinate multifaceted projects, including multitasking, deliverables management and timeline management
- Experience growing a team in meeting company growth objectives
- Self-driven, starter who is comfortable in fast-paced environment
- Effective leadership and communication skills
- Able to organize and prioritize diverse responsibilities to achieve company goals
- Demonstrates strong leadership capabilities with the ability to lead multiple projects through a complex development program
- Handles tight timelines and stress in a constructive manner
- High attention to detail, with the ability to create clear and concise technical documentation
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