Biorepository Director/Lead (ADX-24-21)

COMPANY SUMMARY:

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. 

POSITION SUMMARY:

The Biorepository Director/Lead will be responsible for the development and optimization of biobank sourcing and sample management strategies critical to the advancement of ArcherDX’s In Vitro Diagnostics development programs. The successful candidate must possess a deep understanding of industry standard practices and innovative trends in biorepository management as they relate to clinical biomarker development, regulated product development, the oncology therapeutic landscape, and the regulatory guidelines for diagnostic submissions. This leader will supervise biorepository staff in all activities related to timely sample sourcing, vendor management, inventory management, instrumentation and future automation. A collaborative approach is essential for this leader as they and their team will interface and work in partnership with multiple cross-functional teams across different locations in support of programs pivotal to ArcherDX. 

RESPONSIBILITIES:

• Lead ArcherDX’s approach to oncology sample lifecycle management from acquisition to archival
• Will manage the Biorepository personnel
• Manage all sourcing, vendor management, inventory management and sample allocation in support of IVD development programs.
• Develop and retain highly skilled and effective Biorepository team to support ongoing programs and future development opportunities
• Strategically partner across ArcherDX on the design and execution of robust and timely sample sourcing and utilization plans
• Leverage advances in the field and employ innovative methodologies in Biorepository management
• Authors and reviews standard operating procedures and adheres to ArcherDX quality standards
• Review Biostatistics workflows, data management, transfer, validation plans, and other SOPs.
• Strategically identify opportunities for improvement of analytical pipelines and data management tools that can enhance data analysis strategies in the clinical setting
• Effectively communicate and discuss complex biorepository and IVD development issues with project teams, upper leadership and external partners
• Identify and lead efforts to improve data infrastructure and processes to support needs of IVD Development
• 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:

• 5+ years of Biorepository or biobank management experience
• 3+ years of supervisory experience
• Experience managing laboratory personnel and equipment
• Experience in biorepository software systems and working with Laboratory Information management systems (LIMS)
• Working knowledge of GCP, GLP and federal and local regulations
• Proven ability to manage timelines and adhere to budgetary requirements
• Experience in interfacing with and presenting to executive leadership and external partners
• Experience building effective teams and manage conflict
• Effective at attracting, developing and retaining talented team members.
• Willing to lead, act as a player-coach and roll up his/her sleeves and do what is necessary to meet project and corporate goals
• Excellent verbal and written communication and presentation skills Excellent project management skills

EDUCATION:

KEY ATTRIBUTES:

• Drive and determination
• Ability to work in a fast paced and dynamic environment
• 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
• Ability to build strong relationships within all parts of the company. Strong communication and presentation skills
• Self-starter
• Driven to perform
• Self-directed: needs little explicit direction
• Able to organize, prioritize, and delegate tasks to efficiently move projects forward.