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)

Required

• 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.

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Compensation

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

Possible “other compensation” elements to include:

• equity grant
• bonus eligible