Clinical Affairs Manager

Adaptive Biotechnologies Corp.

. Plan, execute, and report company-sponsored clinical studies supporting IVD product submissions, label claims, clinical evidence generation, and post-market obligations .

Posted 10/22/2026full-timeRemote • United StatesSeniorLead💰 $114,600 - $172,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing clinical studies, including protocol development, regulatory submissions, and compliance with GCP and ISO standards. Proficient in authoring technical documentation and collaborating across functions to ensure clinical data integrity and submission readiness.

Highest-signal resume keywords

Clinical Study ManagementRegulatory Submission AuthoringGCP ComplianceClinical Affairs SOP DevelopmentCRO Oversight

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study DesignProtocol DevelopmentData ManagementBiostatisticsClinical Evidence GenerationTrial Master File ManagementSafety ReportingDeviation ManagementQuality Management System IntegrationTechnical Documentation Authoring

Soft Skills

Cross-Functional CommunicationProject ManagementScientific Writing

Tools & Technologies

Electronic Data Capture SystemsClinical Trial Management Systems

Industry Keywords

IVDMedical DeviceClinical OperationsClinical ResearchISO 14155ISO 2091621 CFR Part 812FDAIVDRMolecular Diagnostics

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Plan, execute, and report company-sponsored clinical studies supporting IVD product submissions, label claims, clinical evidence generation, and post-market obligations
Develop and implement Clinical Affairs SOPs and processes covering study feasibility, protocol development, IRB/EC submissions, informed consent, site qualification and initiation, monitoring, deviation management, safety reporting, data management interface, trial master file management, and study closeout
Establish trial master file structure, document control conventions, clinical training materials, and study templates integrated with the Quality Management System
Define CRO and clinical vendor qualification, contracting, oversight, quality agreement, and performance metric frameworks
Serve as sponsor-side operational lead for active clinical studies, including protocol authorship, site and vendor management, monitoring oversight, deviation and safety event escalation, and clinical study report delivery
Author and coordinate clinical sections of 510(k), De Novo, PMA, IDE, CE technical documentation, IVDR performance evaluation reports, and related regulatory submission content
Track and communicate study status, budgets, timelines, risks, and mitigation plans to Regulatory leadership
Partner with Biostatistics, Data Management, Development, and Quality to ensure clinical data are analyzable, traceable, inspection-ready, and submission-ready
Liaise between Regulatory Affairs and Medical Affairs on clinical evidence topics, study design, intended claims, publication strategy, and post-market evidence planning
Route Medical Affairs input into protocol development, results interpretation, clinical study report narratives, KOL/advisory input, and external presentation development
Partner with Marketing and Market Access to ensure product claims are scientifically defensible and traceable to clinical evidence
Maintain study inspection readiness and compliance with applicable GCP, 21 CFR Part 812, ISO 14155, ISO 20916, IVDR, and analogous international requirements
Monitor evolving FDA, IVDR, ICH, and CLSI expectations and recommend updates to SOPs, templates, and study practices
Mentor future Clinical Affairs hires as the function scales, without direct-report responsibility unless formally adjusted
Perform all other duties as assigned

Requirements

What you’ll need

Bachelor’s degree in life science, engineering, clinical discipline, or related scientific field; advanced degree preferred
7+ years of clinical affairs, clinical operations, or clinical research experience in the medical device, IVD, diagnostic, or molecular diagnostics industry; 5+ years may be considered with an advanced degree
Direct hands-on experience running sponsor-side clinical studies under GCP and one or more applicable clinical study frameworks, including 21 CFR Part 812, ISO 14155, or ISO 20916
Demonstrated experience authoring clinical sections of FDA submissions and/or CE/IVDR technical documentation
Experience building or materially improving Clinical Affairs SOPs, templates, trial master file structures, or related clinical study infrastructure
CRO and clinical vendor oversight experience, including quality agreements, issue escalation, and vendor performance management
Working knowledge of biostatistics, clinical data management, electronic data capture systems, and clinical evidence generation
Excellent scientific writing, cross-functional communication, and project management skills
Adaptive is not currently sponsoring candidates requiring work authorization support for this position

Benefits

Comp & perks

Equity grant
Bonus eligible
Occasional domestic and international travel for clinical site visits, investigator meetings, vendor oversight activities, audits/inspections, conferences, and cross-functional business meetings
Adaptive benefits package (details referenced via benefits-at-a-glance link)