Clinical Affairs Manager

At Adaptive, we’re Powering the Age of Immune Medicine. Our goal is to harness the power of the adaptive immune system to transform the way diseases are diagnosed and treated. As an Adapter, you’ll have the opportunity to make a difference in people’s lives. With Adaptive, you’ll create a career highlight through collaboration with bright, curious colleagues working at the apex of innovation and application. It’s time for your next chapter. Discover your story with Adaptive. Position Overview The Clinical Affairs Manager is a senior individual contributor responsible for planning, executing, and reporting company-sponsored clinical studies that support IVD product submissions, label claims, clinical evidence generation, and post-market obligations. This role will help build and operationalize the company’s Clinical Affairs infrastructure, including SOPs, templates, trial master file structure, CRO/vendor oversight practices, and study governance, while serving as a key liaison between Regulatory Affairs, Medical Affairs, Development, Quality, Biostatistics, Data Management, and commercial stakeholders. Key Responsibilities and Essential Functions Clinical Affairs Infrastructure & Function Build • Develop and implement Clinical Affairs SOPs and processes for 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 TMF structure, document control conventions, clinical training materials, and study templates integrated with the existing Quality Management System. • Define CRO and clinical vendor qualification, contracting, oversight, quality agreement, and performance metric frameworks. Clinical Study Execution & Regulatory Submission Support • 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 delivery of clinical study reports. • Author and coordinate clinical sections of regulatory submissions, including 510(k), De Novo, PMA, IDE, CE technical documentation, IVDR performance evaluation reports, and related submission content in partnership with Regulatory Affairs leads. • Track and communicate study status, budgets, timelines, risks, and mitigation plans to Regulatory leadership on an established cadence. • Partner with Biostatistics, Data Management, Development, and Quality to ensure clinical data are analyzable, traceable, inspection-ready, and submission-ready. Medical Affairs Interface & Evidence Planning • Serve as a key liaison between Regulatory Affairs and Medical Affairs on clinical evidence topics, including study design, intended claims, publication strategy, and post-market evidence planning. • Route Medical Affairs input into protocol development, interpretation of results, 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. Compliance, Inspection Readiness & Function Scaling • Maintain study inspection readiness and ensure Clinical Affairs activities are conducted in accordance with applicable GCP expectations, 21 CFR Part 812 as applicable, ISO 14155, ISO 20916, IVDR, and analogous international requirements. • Monitor evolving FDA, IVDR, ICH, and CLSI expectations for clinical performance evidence and recommend updates to SOPs, templates, and study practices as needed. • Mentor future Clinical Affairs hires as the function scales, without direct-report responsibility unless formally adjus