Adaptive Biotechnologies Corp.

Compliance

• Lead development and execution of ex-US regulatory strategy for NGS-based IVD products.
• Prioritize EU IVDR and Health Canada regulatory activities, including technical documentation, Notified Body engagement, PRRC responsibilities, EU Declaration of Conformity, and Medical Device License applications.
• Build regulatory roadmaps for international expansion, including market-entry sequencing, gap assessments, and localization requirements.
• Serve as primary contact and lead negotiator with international regulatory authorities and Notified Bodies.
• Monitor global regulatory intelligence and translate changes into actionable strategy and process updates.
• Own international technical files, design dossiers, and post-market surveillance/vigilance reporting obligations.
• Lead regulatory activities for biopharma co-development and companion diagnostic partnerships.
• Align CDx regulatory strategy with partner drug development timelines and support labeling, indications for use, and co-development agreements.
• Maintain working knowledge of US FDA pathways and align global submission content, labeling, and change control assessments.
• Support international clinical trial and clinical program regulatory planning.
• Mentor junior Regulatory team members and provide technical and strategic guidance.
• Collaborate with R&D, Quality, and cross-functional product development teams.
• Communicate risk assessments and mitigation plans to leadership.
• Contribute to budgeting, resourcing, and SOP development for international regulatory operations.
• Domestic and international travel required, estimated at 10%.

Senior Manager, Regulatory Affairs

• Assist with assembling regulatory submissions required to market new or modified in vitro diagnostic devices (IVD) in the US and international markets
• Maintain FDA submission files and records, ex-US technical file documentation, and other regulatory documents and policies
• Assist in writing and implementing process improvements for Regulatory Affairs functions
• Maintain and perform regulatory document filing and retrieval in conjunction with SOPs
• Compile, coordinate, and format materials required in submissions, license applications, and technical file documentation
• Maintain files related to FDA/global regulatory registrations, including communications with FDA/global regulatory agencies
• Coordinate and format submissions per FDA and other global health authority requirements
• Assist in creating and implementing regulatory affairs policies and procedures
• Review incoming project contracts and provide guidance on regulatory requirements
• Inform cross-functional teams about new or revised standards, expanded claims, recalls, adverse events, and impacts on IVD products
• Perform all other duties as assigned

Regulatory Affairs Associate

Director

• Lead Adaptive Biotechnologies’ Real-world Evidence team
• Build, shape, and leverage Adaptive’s real-world data strategy to support, validate, and describe the scientific and clinical value of its products
• Establish Adaptive as a leader in rigorous, reproducible, and regulatory-grade evidence generation
• Define the vision, priorities, and roadmap for Adaptive’s real-world data platform and evidence generation
• Build the cross-functional team and partnerships needed to execute the real-world data strategy
• Partner with Product Management, IT Engineering, R&D, Medical Affairs, Customer Operations, Market Access, Commercial Technology Strategy, and Legal
• Lead strategy for using real-world data to unlock the clinical and commercial value of Adaptive products
• Shape enterprise data strategy and identify opportunities for corporate growth, market differentiation, and strategic partnerships
• Define and own evidence roadmaps supporting clinical decision-making, regulatory and payor engagement, market access, and physician adoption
• Translate product, clinical, and commercial priorities into RWE strategies, study concepts, data requirements, analytic approaches, timelines, and resourcing needs
• Prioritize initiatives across disease indications and external pharmaceutical partnership opportunities
• Build, lead, and develop an organization of RWE Analysts and data engineers
• Manage functional operating budgets, external data investments, technology investments, and strategic partnership spend
• Define data requirements, data models, and governance needs for priority real-world data use cases
• Guide development and curation of internal and external real-world data sources, including clinical data partnerships and linked datasets
• Oversee statistical analysis plans and analytic approaches for RWE studies
• Ensure studies meet standards for reproducibility, transparency, scientific rigor, and stakeholder relevance
• Translate study results into scientific and business recommendations
• Develop presentations, abstracts, manuscripts, and external-facing materials
• Represent Adaptive externally as a thought leader in real-world data and evidence generation
• Establish team goals, provide coaching and feedback, and foster belonging, respect, and open communication

Senior Director, Real World Evidence

Insurance

• Review and analyze delayed or denied claims to determine root cause based on payer explanation of benefits or remittance advice
• Conduct timely follow up with insurance carriers to clarify claim status, resolve issues, and secure payment
• Obtain missing information, correct coding or billing errors, and submit corrected claims or resubmissions
• Escalate unresolved or complex claims to Appeal Specialists or management
• Research and interpret payer coverage policies, contracts, and medical necessity requirements related to molecular and NGS testing
• Document follow up activity, payer communication, and resolution steps within the billing system
• Ensure compliance with HIPAA, payer rules, and internal company policies
• Collaborate with prior authorization, billing, reimbursement, and client services teams
• Communicate with providers and internal stakeholders to resolve claim discrepancies or obtain information
• Track claim statuses, denial reasons, resolution timelines, and follow up outcomes
• Identify denial and delay trends and help implement strategies to reduce future denials
• Provide workflow and process improvement feedback to enhance revenue cycle efficiency
• Manage incoming single-case agreements or LOAs and negotiate appropriate reimbursement rates
• Provide single-case agreement trends to contracting and payer relations teams
• Perform other duties as assigned

Insurance Specialist

General

• Review denied claims and determine appropriate appeal strategy based on payer guidelines
• Prepare and submit appeal letters with supporting documentation
• Submit appeals through payer-preferred portals, fax, or mail within payer-specific timelines
• Track appeal status and maintain accurate billing-system records
• Contact insurance companies to confirm receipt and appeal progress
• Escalate unresolved appeals or complex cases to management
• Stay current on payer policies and appeal requirements for molecular and genetic testing
• Ensure appeal activities comply with HIPAA and regulatory standards
• Identify denial trends and collaborate with reimbursement teams to reduce future occurrences
• Collaborate with prior authorization, billing, and payer relations teams
• Communicate with providers when additional clinical information is required
• Perform other duties as assigned

Appeals Specialist

Artificial Intelligence

• Support Enterprise AI Program Office work across assigned workstreams, business areas, stakeholder groups, governance backlog items, enablement activities, and special initiatives
• Shape, assess, and route AI opportunities by clarifying business value, user population, data sensitivity, workflow impact, autonomy level, vendor/tool status, regulated process exposure, technical dependencies, adoption needs, and support model
• Maintain the enterprise AI portfolio and backlog across business use cases, roadmaps, platform requests, AI tools, pilots, production candidates, adoption initiatives, and workforce enablement activities
• Coordinate risk-triggered governance and control activities with Legal, Privacy, Information Security, QA/Compliance, Enterprise Architecture, SWE, IT, data owners, business owners, and other accountable subject matter experts
• Prepare and maintain intake records, decision logs, AI impact assessments, review packets, action logs, risk registers, exception records, readiness checklists, service-model documentation, and evidence records
• Build reusable program office assets including service catalog content, intake guidance, assessment criteria, starter kits, tool-selection guidance, playbooks, templates, FAQs, office-hours materials, and training support materials
• Support functional AI leaders and business stakeholders by gathering needs, adoption barriers, tool feedback, success stories, recurring questions, and demand signals
• Coordinate readiness checkpoints with engineering, software engineering, enterprise architecture, IT, data architecture, vendors, and platform partners
• Track AI-related issues, incidents, near misses, policy exceptions, duplicated efforts, unclear ownership, blocked handoffs, adoption friction, and lessons learned
• Prepare sponsor and executive reporting inputs, including portfolio dashboards, roadmap updates, operational metrics, adoption signals, risks, open decisions, RAID summaries, and recommended next actions
• Continuously improve AI intake, opportunity assessment, prioritization, governance routing, pilot launch, scaling, engagement, service request, and benefit-tracking processes
• Perform other duties as assigned
• Report to the Director, Enterprise AI Program Office

Senior Manager, Regulatory Affairs

Regulatory Affairs Associate

Senior Director, Real World Evidence

Insurance Specialist

Appeals Specialist

Senior AI Governance Analyst