Clinical Affairs Manager

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $114.6k - $172k / year

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

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Adaptive Biotechnologies Corp.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2009

🏥 Healthcare

🧬 Biotechnology

⚕️ Healthcare Insurance

💰 $125M Post-IPO Debt on 2022-09

Healthcare • Biotechnology • Healthcare Insurance

Adaptive Biotechnologies Corp. is a leader in immune-driven medicine, aiming to revolutionize disease detection and treatment. By utilizing the adaptive immune system, the company develops diagnostic and therapeutic solutions powered by its innovative Immune Medicine platform. They offer clinical diagnostics, particularly in Minimal Residual Disease (MRD) testing, and engage in drug discovery and therapeutic development through adaptive immunosequencing technologies. Their biopharma services support the progression of clinical trials and the development of transformative medicines. Adaptive Biotechnologies leverages the complex biology of the immune system, decoding it to advance medical science and improve patient outcomes.

📋 Description

• 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

• 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

• 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)