Clinical Affairs Manager

Adaptive Biotechnologies Corp.; United States; On-site; USD 115,000 - 172,000; Full time

Benefits offered by this job

Equity grant

Bonus eligible

Job summary

Adaptive Biotechnologies Corp. seeks a Senior Clinical Affairs Manager to lead sponsor-side clinical studies, support regulatory submissions for IVD products, and help build scalable clinical infrastructure across Regulatory, Medical, Development, and Quality teams.

You will drive SOP development, TMF management, vendor oversight, and cross-functional collaboration to advance clinical evidence while ensuring post-market compliance in a fast-paced biotech environment.

Qualifications

• Bachelor's degree in life science, engineering, clinical discipline, or related field (advanced degree preferred).
• 7+ years in clinical affairs, clinical operations, or clinical research in medical device/IVD/molecular diagnostics.
• Experience running sponsor-side clinical studies under GCP and 21 CFR Part 812/ISO 14155/ISO 20916.
• Experience authoring clinical sections of FDA submissions and/or CE/IVDR documentation.
• Experience building or improving Clinical Affairs SOPs, templates, and TMF structures.
• CRO/vendor oversight including quality agreements and performance management.

Responsibilities

• Develop and implement Clinical Affairs SOPs and processes (feasibility, protocol development, IRB submissions, consent, site initiation, monitoring, safety reporting, data management interface, TMF).
• Lead sponsor-side clinical study execution, including protocol authorship, site/vendor management, monitoring, safety escalation, and study reports.
• Author regulatory submission content and coordinate with Regulatory Affairs leads.
• Ensure data are analyzable, traceable, inspection-ready, and submission-ready.
• Serve as liaison between Regulatory Affairs and Medical Affairs on evidence planning and publication strategy.

Skills

Scientific writing

Cross-functional communication

Project management

GCP knowledge

FDA submissions experience

Education

Bachelor's degree in life science or related field

Advanced degree preferred

Tools

Electronic data capture systems

Job description

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 adjusted.
• All other duties as assigned

Position Requirements (Education, Experience, Other)

• 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.

Preferred

• IVD, NGS assay, or complex molecular diagnostic clinical validation experience, including method comparison, reference interval, clinical concordance, or other studies aligned with CLSI guidance.
• Prior experience standing up a Clinical Affairs function, building a function from a small footprint, or implementing scalable clinical study infrastructure.
• Direct interface experience with Medical Affairs, KOLs, investigators, scientific advisory boards, or publication planning activities.
• Certification such as ACRP-CP, SOCRA CCRP, or equivalent clinical credential.
• Experience with post-market clinical performance follow-up or post-market performance follow-up under IVDR.

Working Conditions

Occasional domestic and international travel may be required for clinical site visits, investigator meetings, vendor oversight activities, audits/inspections, conferences, and cross-functional business meetings.

Compensation

Salary Range: $114,600 - $172,000

Possible “other Compensation” Elements To Include

• equity grant
• bonus eligible

Adaptive is not currently sponsoring candidates requiring work authorization support for this position.

Adaptive’s posted compensation information includes a base salary (or hourly rate) range and summary of other available total compensation. The base salary range represents a minimum-to-maximum salary (or hourly rate) available to candidates upon extension of offer. Base salary is thoughtfully considered upon offer and is determined through multiple evaluation checks throughout the interview process, including: a candidate’s ability to meet minimum qualifications (skills/experience/education), a candidate’s ability to thoughtfully address preferred qualifications, current market conditions, and internal pay equity. Listed base salary is exclusive of bonus, commission, equity, differential pay, benefits, and other incentives.

Adaptive Biotechnologies is an Aff

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability. Please refer the “Know Your Rights: Workplace Discrimination is Illegal” Poster for more information. If you’d like to view a copy of the company’s affirmative action plan or policy statement, please email [e-mail].

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NOTE TO EMPLOYMENT AGENCIES

Adaptive Biotechnologies values our relationships with our Recruitment Partners and will only accept resumes from those partners who have active agreements with Adaptive. Adaptive Biotechnologies is not responsible for any fees related to resumes that are unsolicited or are received by any employee of Adaptive Biotechnologies who is not a member of the Human Resources team.