Director, Clinical Compliance

Jade Biosciences

Director of Clinical Compliance collaborating with study teams to maintain inspection readiness and operational quality. Guiding compliance across clinical trials and vendor oversight in a biotech setting.

Posted 6/26/2026full-timeRemote • California, Washington • 🇺🇸 United StatesLead💰 $210,000 - $235,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Serve as a trusted GCP compliance advisor to all functions within study teams by promoting a culture of quality and helping teams integrate compliant practices into daily study execution and decision-making
Analyze compliance metrics, audit findings, monitoring data, and operational trends across programs to identify systemic risks and opportunities for process improvement
Apply risk-based judgment in interpreting and implementing GCP requirements, balancing regulatory expectations with operational realities to ensure compliance approaches are practical, defensible, and appropriate to the level of risk
Drive initiatives to ensure continuous inspection readiness across clinical studies
Assist in preparation for regulatory inspections and internal audits including readiness assessments and document reviews
Support development of inspection storyboards and response strategies when needed
Ensure study teams maintain inspection-ready documentation and evidence of ongoing compliance
Support oversight of CROs and other clinical vendors to ensure compliance with contractual and regulatory expectations
Partner with Development Outsourcing on defining and tracking vendor performance metrics and KPIs
Participate in vendor governance meetings and performance reviews
Identify trends or risks in vendor performance and recommend mitigation strategies
Review and track vendor QEs
Develop processes for oversight of monitoring activities conducted by CROs
Review monitoring oversight plans, reports, and monitoring metrics
Assess monitoring quality and compliance with monitoring plans
Identify monitoring gaps and collaborate with study teams to address them
Support identification and management of investigator or site non-compliance
Assist study teams in evaluating protocol deviations and escalation needs
Help develop remediation strategies for significant compliance issues
Support study teams in identifying and appropriately escalating significant compliance issues, protocol deviations, and site noncompliance, ensuring issues are investigated, documented, and resolved in accordance with regulatory expectations
Drive and support development and implementation of CAPAs from audits, inspections, or compliance reviews
Track CAPA effectiveness and ensure timely closure
Identify recurring issues and support continuous improvement initiatives
Partner with QA to support internal and external GCP audits
Assist with audit preparation and documentation review
Support study teams in addressing audit findings
Provide training to clinical teams on ICH-GCP, regulatory requirements, and internal SOPs
Identify knowledge gaps and support development of compliance training programs
Contribute to SOPs, guidance documents, and best practice materials.

Requirements

What you’ll need

Bachelors + 15 years or Masters + 12 years or PhD + 8 years of related experience with 10+ years of relevant experience in biotech/pharma or CRO roles in Clinical Operations and/or Clinical Quality Assurance (GCP)
Excellent communication, organizational, negotiation, and interpersonal skills with a strong reputation for collaboration
Experience managing, coaching, and mentoring personnel
Experience supporting global clinical trials in sponsor or CRO environments
Strong working knowledge of ICH-GCP and global regulatory requirements
Experience supporting GCP audits or regulatory inspections
Experience with vendor oversight and CRO management
Experience developing or implementing CAPAs.

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Jade Biosciences Website LinkedIn All Job Openings 11 - 50 employees Founded 2024 🧬 Biotechnology 💊 Pharmaceuticals Biotechnology
Pharmaceuticals Jade Biosciences is a clinical-stage biotechnology company developing potentially best-in-class therapies aimed at transforming the standard of care for autoimmune diseases. Its lead candidate, JADE101, is an antibody designed to inhibit the cytokine APRIL (A PRoliferation-Inducing Ligand) and is being developed for the treatment of immunoglobulin A nephropathy (IgAN). The company builds its pipeline from discovery-stage assets licensed from Paragon Therapeutics and is focused on advancing clinical programs to deliver new treatments for patients with autoimmune conditions. Director, Clinical Compliance 🔥 3 minutes ago 🏄 California, Washington – Remote 💵 $210k - $235k / year ⏰ Full Time 🔴 Lead 👨‍⚕️ Medical Director Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
Serve as a trusted GCP compliance advisor to all functions within study teams by promoting a culture of quality and helping teams integrate compliant practices into daily study execution and decision-making
Analyze compliance metrics, audit findings, monitoring data, and operational trends across programs to identify systemic risks and opportunities for process improvement
Apply risk-based judgment in interpreting and implementing GCP requirements, balancing regulatory expectations with operational realities to ensure compliance approaches are practical, defensible, and appropriate to the level of risk
Drive initiatives to ensure continuous inspection readiness across clinical studies
Assist in preparation for regulatory inspections and internal audits including readiness assessments and document reviews
Support development of inspection storyboards and response strategies when needed
Ensure study teams maintain inspection-ready documentation and evidence of ongoing compliance
Support oversight of CROs and other clinical vendors to ensure compliance with contractual and regulatory expectations
Partner with Development Outsourcing on defining and tracking vendor performance metrics and KPIs
Participate in vendor governance meetings and performance reviews
Identify trends or risks in vendor performance and recommend mitigation strategies
Review and track vendor QEs
Develop processes for oversight of monitoring activities conducted by CROs
Review monitoring oversight plans, reports, and monitoring metrics
Assess monitoring quality and compliance with monitoring plans
Identify monitoring gaps and collaborate with study teams to address them
Support identification and management of investigator or site non-compliance
Assist study teams in evaluating protocol deviations and escalation needs
Help develop remediation strategies for significant compliance issues
Support study teams in identifying and appropriately escalating significant compliance issues, protocol deviations, and site noncompliance, ensuring issues are investigated, documented, and resolved in accordance with regulatory expectations
Drive and support development and implementation of CAPAs from audits, inspections, or compliance reviews
Track CAPA effectiveness and ensure timely closure
Identify recurring issues and support continuous improvement initiatives
Partner with QA to support internal and external GCP audits
Assist with audit preparation and documentation review
Support study teams in addressing audit findings
Provide training to clinical teams on ICH-GCP, regulatory requirements, and internal SOPs
Identify knowledge gaps and support development of compliance training programs
Contribute to SOPs, guidance documents, and best practice materials. 🎯 Requirements
Bachelors + 15 years or Masters + 12 years or PhD + 8 years of related experience with 10+ years of relevant experience in biotech/pharma or CRO roles in Clinical Operations and/or Clinical Quality Assurance (GCP)
Excellent communication, organizational, negotiation, and interpersonal skills with a strong reputation for collaboration
Experience managing, coaching, and mentoring personnel
Experience supporting global clinical trials in sponsor or CRO environments
Strong working knowledge of ICH-GCP and global regulatory requirements
Experience supporting GCP audits or regulatory inspections
Experience with vendor oversight and CRO management
Experience developing or implementing CAPAs. Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs Director of Implementation – Healthcare SaaS 🔥 33 minutes ago SoluStaff 51 - 200 🎯 Recruiter 👥 HR Tech Website LinkedIn All Job Openings Director of Implementation at a healthcare technology organization overseeing customer onboarding and integration strategies. Driving implementation methodologies and ensuring successful project outcomes. 🇺🇸 United States – Remote ⏰ Full Time 🔴 Lead 👨‍⚕️ Medical Director Director, Healthcare Services 🔥 34 minutes ago Transact Campus 501 - 1000 Website LinkedIn All Job Openings Director of Healthcare Services leading a team for Illumia's healthcare solutions, ensuring effective implementations and client satisfaction across various healthcare environments. 🇺🇸 United States – Remote 💵 $120k - $175k / year ⏰ Full Time 🔴 Lead 👨‍⚕️ Medical Director 🦅 H1B Visa Sponsor Healthcare Consulting Director – Case Management 🔥 1 hour ago Huron 5001 - 10000 🤝 B2B 🏢 Enterprise 💸 Finance Website LinkedIn All Job Openings Healthcare Consulting Director in Clinical Enterprise - Case Management leading performance improvement initiatives. Managing teams to optimize processes and drive clinical outcomes in healthcare organizations. 🇺🇸 United States – Remote 💵 $185k - $250k / year ⏰ Full Time 🔴 Lead 👨‍⚕️ Medical Director 🦅 H1B Visa Sponsor Director, Medical Affairs – Clinical Microbiology 🔥 1 hour ago Waters Corporation 10,000+ employees 💊 Pharmaceuticals 🧬 Biotechnology 🔬 Science Website LinkedIn All Job Openings Director of Medical Affairs providing strategic and scientific leadership at Waters Corporation. Collaborating across teams to develop innovative diagnostics in microbiology and laboratory medicine. 🇺🇸 United States – Remote 💵 $184.2k - $294.8k / year ⏰ Full Time 🔴 Lead 👨‍⚕️ Medical Director Medical Affairs Scientific Communications Director – Movement Disorders 🔥 4 hours ago Cookie Information 51 - 200 🤝 B2B 📋 Compliance Website LinkedIn All Job Openings Director of Medical Affairs Scientific Communications at Lundbeck developing strategies for MSA. Overseeing publication planning and cross-functional collaboration to support launch readiness. 🇺🇸 United States – Remote 💵 $260k - $290k / year ⏰ Full Time 🔴 Lead 👨‍⚕️ Medical Director View More Medical Director Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs

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Hard Skills & Tools

GCP compliancerisk-based judgmentCAPA developmentaudit preparationmonitoring quality assessmentprotocol deviation evaluationvendor performance metricscompliance training program developmentinspection readinessclinical quality assurance

Soft Skills

communicationorganizational skillsnegotiationinterpersonal skillscollaborationcoachingmentoring