Jade Biosciences
Director, Clinical Compliance
Remote; San Francisco; Seattle · Director
Sponsorship not specified$210k-$235kDetected 25 days ago
GCPNegotiationProcess ImprovementPerformance ManagementClinical TrialsAnimal StudiesCommunicationCollaborationMentoring
About the role
- The Director, Clinical Compliance collaborates with internal and external stakeholders to ensure that clinical trials conducted by Jade adhere to ICH-GCP, regulatory requirements, internal SOPs, and quality standards.
- Embedded within the Development Operations Operational Excellence team, this role functions as an internal GCP compliance leader who partners closely with study teams, vendors, and Quality Assurance (QA) to maintain inspection readiness and operational quality across all clinical programs.
- This individual will lead initiatives related to vendor oversight, monitoring oversight, compliance metrics and issue management and escalation, while serving as a key liaison between Clinical Operations and the GCP Quality organization during audits and regulatory inspections.
Responsibilities
- 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
- Develop processes for oversight of monitoring activities conducted by CROs
- Identify monitoring gaps and collaborate with study teams to address them
- Support identification and management of investigator or site non-compliance
- Help develop remediation strategies for significant compliance issues
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)
- 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
- periodic travel to team and company events is required.
- Excellent communication, organizational, negotiation, and interpersonal skills with a strong reputation for collaboration
- Experience developing or implementing CAPAs
Compensation
- The anticipated salary range for candidates for this role is $210,000 - $235,000.
Visa & Work Authorization
- Experience supporting global clinical trials in sponsor or CRO environments
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