Adaptive Biotechnologies Corp.

Operations

• CLD of record for all clinical laboratory licenses.
• Manages other CLDs, and ensures appropriate and timely cross-functional support from the CLD team to the rest of the CLO team as needed and requested: Compliance/Quality, Clinical and Technical functions within CLO and applicable to CLIA, CAP, CLEP regulations.
• Manages the Technical Production group that provides RUO data QC, assay health assessments and related technical troubleshooting and support to the CLDs, VP MLO/Head Clinical Laboratory Director, and CLO function as a whole.
• Develops deep system and function knowledge for assay data QC and clinical reporting activities.
• Collaborates with the Laboratory Operations Staff and clinical services to ensure timely and accurate result reporting.
• Proactively develops and shares dashboards indicating status and alerts for clinical diagnostic turnaround and Clinical and technical functions.
• Develops clinical knowledge for assays in the production laboratory and provides consults to ordering physicians, leverages team to cover consults for all assays in clinical production.
• Supports, and coordinates schedules for daily clinical data QC to ensure needed coverage.
• Manages clinical reporting activities and capacity planning for the group to ensure staffing levels are appropriate to meet forecasted need.
• Hires, onboards, mentors, trains and retains talented staff to cover required strategic and tactical needs of the group and the organization.
• Manages time of self and team, delegates and tracks work and related projects to ensure effective and efficient delivery on schedule, per agreed timelines.
• Builds good working relationships with the Medical Affairs team, Clinical Services and others, as needed to be effective and efficient with respect to Clinical team needs.
• Acts as a trusted advisor across the company and is recognized as a functional expert for the Clinical Laboratory Director team.
• Represents the CLD functions on product development teams, as needed and appropriate, leverages team to support such activities, including but not limited to: clinical report content and approval, clinical data QC and reporting software requirements, input and approval for key assay design and process requirements and decisions, review and approval of analytical and clinical studies.
• Ensures inspection readiness and proactively address quality and compliance issues by performing periodic internal audits of the CLO lab for CLIA/CAP/CLEP compliance.
• Serves as a liaison for Adaptive during inspection by external agencies and pharma partners.
• Collaborates closely with senior leaders to provide cohesive direction towards company and CLO goals and supports company strategy both internally and externally.
• Able to navigate complex situations and problems through to resolution, and propose appropriate and compliant solutions.
• Influences the opinions and decision-making of others, including executives and makes appropriate decisions that affect the success of the CLD team and CLO as a whole.
• Works cross-functionally with relevant teams to optimize resource use, build relevant relations and ensure effective cross-functional communication and alignment.
• Contributes to continuous improvement initiatives by championing and, when applicable, leading opportunities to improve quality and efficiency for Clinical activities, champions operational improvements to reduce CLD workload.
• Support LIMS Development in collaboration with the software team (e.g., generates user requirements, UAT cases and plans, completes test plans), reviews and approves related documents for system features and enhancements, as required/requested.
• Author and/or approve documents relevant to the clinical aspects of the CLD role.
• Collaborates with VP MLO, and Head Clinical Laboratory Director to develop and continuously improve day-to-day operations and ensure cross-functional alignment with other CLO groups, as requested.
• Upholds clinical laboratory best practices and complies with applicable regulations.
• Promotes a positive work environment while supporting management and business goals.
• Regulatory responsibilities of “Laboratory Director” for high complexity testing as defined by 42CFR493.1445 and the College of American Pathologist Director Assessment Checklist.
• Regulatory responsibilities (when delegated) of “Technical Supervisor” for high complexity testing as defined by 42CFR493.1451.
• Regulatory responsibilities of “Clinical Consultant” for high complexity testing as defined by 42CFR493.1457.
• Regulatory responsibilities per Good Laboratory Practices (GLP).

Senior Director, Clinical, CLD Operations

IT Support

• Prioritize infrastructure projects and present solutions for maturity and scale
• Analyze technical and serviced based solutions and provide cost-benefit analysis for proposals
• Managing external vendor relationships including contract negotiations, RFP's and statements of work
• Manage business continuity and recovery of company’s information systems, including needs analysis, design, plan development, implementation and documentation
• Lead systems administration, maintenance, back up, restoration and performance optimization in conjunction with external support vendors
• Manage the company’s development, deployment and execution of controls and defenses to ensure the security of company technology and information
• Analyze business needs and establish priorities for protection of critical systems and operational policies
• Establish and implement appropriate standards and criteria for hardware, software, email and web firewall, access and encryption requirements, evaluate potential business impacts from security breaches and provide strategic and tactical guidance to business decision-makers
• Ensure the security and protection of company systems and data by maintaining compliance with Adaptive security and information handling policies.
• All other duties as assigned.

Senior Manager, IT Infrastructure

Project Manager

• Lead internal research projects from initiation through completion, including scope definition, planning, execution, and documentation.
• Track external collaborative research projects to develop and maintain study workflows, assess progress, proactively manage risks, and support timely data availability for analysis, publication and presentation at key congresses.
• Ensure alignment on project goals, rationale, and roles & responsibilities with stakeholders and leadership.
• Develop and maintain project charters, timelines and work plans, driving accountability across the team.
• Facilitate clear communication across project teams, internal partners, functional leaders, and external collaborators.
• Identify and manage risks and issues, proactively communicating and adjusting plans as needed.
• Partner with other Program and Project Managers across Adaptive to support infrastructure for project management, prioritization, communication, and institutional knowledge sharing.
• Participate in cross-functional initiatives as a contributing team member.
• Perform / support analysis to inform business case and resource allocation
• Define metrics for project success and determine how to measure
• Provide regular reporting on project status to manager and project team, highlighting key risks, issues, and milestones.
• Contribute to the development and execution of research studies that support MRD product and commercial strategy
• Clinical study execution support: Track protocol development, contracting, study start-up, and coordinate cross-functional operational workflows (Regulatory/IRB, Clinical Trials, lab teams).
• IRB protocol coordination: Facilitate IRB protocol submissions and related materials; track IRB protocol progress, approvals, and renewal dates; and coordinate record updates and amendments as required to ensure protocols do not lapse and study activities remain appropriately covered.
• Visibility + stakeholder communication: Provide clear status reporting, surface critical-path risks, and align on mitigation/alternative plans with Medical Affairs leadership and key stakeholders.
• Scientific output enablement: Track data generation and publication/congress timelines, maintain data-readiness visibility, and build/maintain tracking tools and outreach tracking for study opportunities/sites.
• All other duties as assigned

Project Manager, Medical Affairs

Business Development Rep

• Drive prospecting and acquisition of new business with pharmaceutical/ industry customers
• Drive negotiation of new contracts and agreements with industry clients
• Oversee lifecycle management of partnerships/projects, including initiation, contracting, order creation and documentation, and deliverables to external stakeholders
• Represent Adaptive externally and deliver scientific presentations to identify opportunities
• Contribute to new bookings and recognized revenue corporate goals
• Work cross-functionally to manage and deliver deal commitments
• Support business development strategy and initiatives
• All other duties as assigned

Strategic Alliance & Business Development Manager

General Counsel

• Draft, review and negotiate contractual arrangements for a range of agreements related to Adaptive’s support of customer clinical trials, including MSAs and SOWs.
• Partner closely with privacy and compliance attorneys and counterparts in finance, quality assurance, security, regulatory and operations.
• Provide support on NDAs, vendor contract reviews, and vendor management matters.
• Advise on and direct internal traffic regarding routine, ongoing legal queries.
• Support internal Legal teams on general legal matters relating to ex-US expansion opportunities.
• Assist with preparation of certain SEC filings, including Forms 10-K and proxy statements.
• Help develop, implement, and maintain contract templates, negotiation playbooks, company policies.
• Keep informed of new laws, regulations, and industry trends affecting Adaptive.

Commercial Counsel

Manager

• Communicates contract terms, payment structures, and reimbursement rates to payers.
• Analyzes financial impact of contracts and terms.
• Maintains contracts and documentation within a tracking system.
• May assist with identifying and recruiting payers based on improving clonoSEQ coverage and reimbursement.
• Begins to influence department’s strategy.
• Makes decisions on moderately complex to complex issues regarding technical approach for project components, and work is performed without direction.
• Exercises considerable latitude in determining objectives and approaches to assignments.
• All other duties as assigned

Senior Director, Clinical, CLD Operations

Senior Manager, IT Infrastructure

Project Manager, Medical Affairs

Strategic Alliance & Business Development Manager

Commercial Counsel

Payer Contracting Manager