Vice President of Regulatory and Quality

Lynd Clinical, Inc.

United, WV 25075, USA

Published: 6/14/2022

Healthcare

Full Time

Job Description

About Lynd Clinical

Lynd Clinical is building a next-generation clinical research site network focused on expanding access to clinical trials while improving the speed, predictability, and quality of study execution.

Our model combines high-quality local clinical research operations with centralized capabilities in patient recruitment, regulatory and quality, business development, technology, and clinical operations. Lynd is building an AI-enabled operating platform designed to improve patient identification, feasibility, recruitment, and study execution across the network.

We are particularly focused on bringing clinical research opportunities to community and underserved markets where large patient populations historically have had limited access to clinical trials. Through acquisitions, new site development, and strategic clinical partnerships, Lynd is building a scalable national research network designed around patients, investigators, sponsors, and operational excellence.

Position Overview

Lynd Clinical is seeking a Vice President of Regulatory & Quality to lead the regulatory, quality, and compliance functions across our growing network of clinical research sites.

This leader will build and scale a consistent regulatory and quality framework across Lynd, ensuring our sites operate with a high level of compliance, operational discipline, and inspection readiness while supporting rapid growth through acquisitions, new site development, and expansion of our clinical trial portfolio.

The Vice President will oversee regulatory operations, quality systems, SOP development and harmonization, audit and inspection readiness, training and compliance, and the integration of newly acquired sites into Lynd's operating framework. This individual will work closely with Clinical Operations, Patient Recruitment, Technology, Business Development, site leadership, and investigators to ensure quality and compliance are built into how Lynd operates every day, while the quality assurance functions keeps the independence it needs to audit and escalate.

The ideal candidate combines deep clinical research regulatory and quality expertise with strong operational judgment and experience scaling systems across a multi-site clinical research organization.

The Vice President, Regulatory & Quality will report to the Chief Operating Officer and has a dotted-line reporting to the Chief Executive Officer on quality and compliance matters and serve as a key member of Lynd's corporate operating leadership team.

Key Responsibilities:

Regulatory Operations

Lead site regulatory strategy and execution across the network, ensuring compliance with ICH E6(R3), 21 CFR Parts 11, 50, 56, and 312 (and Part 812 for device studies), HIPAA, IRB and sponsor requirements, applicable state requirements, and Lynd policies.

Build and oversee a scalable centralized regulatory function covering study start-up, ongoing maintenance, amendments, renewals, safety reporting, and closeout, with standardized workflows and documentation requirements across sites.

Partner with Clinical Operations and Business Development to accelerate study start-up, and manage workflows with central and local IRBs, sponsors, CROs, and investigators.

Keep regulatory documentation and electronic regulatory systems complete, current, and inspection-ready.

Quality Management

Own and develop Lynd's Quality Management System, including company-wide SOPs, policies, and work instructions aligned with ICH E6(R3) and harmonize them across acquired and newly developed sites.

Run a risk-based quality management approach that prioritizes participant safety, data integrity (ALCOA+), protocol compliance, and operational consistency.

Establish one set of regulatory and quality KPIs covering start-up and submission turnaround, deviations,

CAPAs, training, and monitoring and audit findings, and reporting them to senior leadership.

Identify systemic issues and recurring trends across sites, and partner with operational leadership on corrective and preventive actions, updated procedures, and training.

Audit & Inspection Readiness

Maintain continuous inspection readiness and run an internal audit program that operates independently of regulatory operations.

Host and lead FDA inspections and sponsor and CRO audits.

Maintain the process for tracking findings, root-cause analysis, CAPAs, and verification of effectiveness.

Conduct for-cause audits and lead investigations of serious noncompliance and suspected misconduct or fraud, including required reporting to IRBs, sponsors, and regulators.

Investigator and Site Oversight

Set and monitor standards for principal investigator oversight, delegation of authority, investigator and staff credentialing, and debarment checks.

Ensure compliance with state licensure and scope-of-practice rules, investigational product and controlled substance accountability, and CLIA requirements across all states where Lynd operates.

Own vendor qualification and oversight for services that affect participant safety or data integrity.

M&A Integration and Site Expansion

Lead regulatory and quality diligence on acquisitions, assessing documentation, SOPs, quality practices, training records, inspection history, and compliance risk.

Develop and execute post-close integration plans with clear milestones and accountability, preserving continuity of active studies and securing record retention for closed studies at acquired sites.

Prepare acquired and de novo sites to be sponsor-ready, inspection-ready, and operationally ready for study activation.

Training & Compliance

Build a scalable training and compliance program covering GCP, SOP, protocol, systems, role-specific, and remedial training, with records and competency requirements that stay current and auditable.

Technology & Process Improvement

Embed regulatory and quality requirements into CRIO and Lynd's other clinical systems, and automate administrative and quality processes while keeping appropriate controls.

Ensure 21 CFR Part 11 compliance and computerized system validation for systems that hold clinical or regulatory records.

Establish governance and quality controls for AI-enabled clinical workflows, including validation, human oversight, and change control, in partnership with Technology leadership.

Leadership & Cross-Functional Partnership

Build and lead a high-performing regulatory and quality organization, and define the balance between centralized resources and site-level responsibilities.

Partner with Clinical Operations leadership, Site Managers, and investigators to turn regulatory requirements into practical operating standards and reinforce a culture of quality and accountability.

Serve as a trusted advisor to senior leadership on regulatory risk, quality trends, and compliance matters.

Qualifications:

Bachelor's degree in a scientific, healthcare, or related field.

10+ years of clinical research experience, including at least 5 years leading regulatory or quality functions.

Direct development and ownership of a Quality Management System across multiple clinical research sites, including developing and harmonizing SOPs.

Significant experience within a clinical research site network, SMO, CRO, or other multi-site clinical trial environment.

Experience hosting or leading FDA inspections and sponsor or CRO audits.

Deep working knowledge of ICH E6(R3), FDA regulations including 21 CFR Part 11, IRB requirements, clinical trial documentation, and eRegulatory systems.

Strong understanding of study start-up, regulatory submissions, and site operations.

Experience developing regulatory and quality KPIs and using data to drive operational improvement.

Strong leadership, communication, and change-management capabilities.

Ability to balance rigorous compliance standards with the speed and pragmatism required in a high-growth organization.

Willingness to travel to fulfill job responsbilities.

Preferred:

Advanced degree.

Professional certification such as RQAP-GCP, CCRP, CCRC, RAC, or ASQ CQA.

Site-level clinical research experience.

Experience integrating acquired clinical research sites or standardizing operations across a rapidly growing organization.

Experience building infrastructure in an entrepreneurial environment while the organization continues to scale.