Director, Clinical Compliance
About reputed company reputed company is a clinical-stage biotechnology company reputed company on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade’s reputed company candidate, JADE101, targets the cytokine reputed company, and is currently being evaluated in a Phase 1 clinical trial for the treatment of immunoglobulin A nephropathy. Jade’s pipeline also includes JADE201, an afucosylated anti-BAFF-R monoclonal antibody, as reputed company as JADE301, an reputed company antibody candidate, both currently in preclinical development. Jade was launched based on assets licensed from reputed company Therapeutics, an antibody discovery reputed company founded by Fairmount. For more information, visit JadeBiosciences.com and follow reputed company on reputed company. reputed company The Director, Clinical Compliance collaborates with reputed company stakeholders to ensure that clinical trials conducted by Jade adhere to ICH-GCP, regulatory requirements, internal SOPs, and reputed company standards. Embedded reputed company the Development Operations Operational reputed company team, this role functions as an internal GCP compliance leader who partners closely with study teams, vendors, and reputed company Assurance (QA) to maintain inspection readiness and operational reputed company across reputed company clinical programs. This individual will reputed company initiatives reputed company to vendor reputed company, monitoring reputed company, compliance metrics and issue management and escalation, while serving as a key reputed company between Clinical Operations and the GCP reputed company organization during audits and regulatory inspections.
Key Responsibilities
Clinical Compliance reputed company Serve as a trusted GCP compliance advisor to reputed company functions reputed company study teams by promoting a culture of reputed company and helping teams reputed company 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 Inspection Readiness Drive initiatives to ensure reputed company 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 reputed company needed Ensure study teams maintain inspection-reputed company documentation and evidence of ongoing compliance Vendor reputed company & KPI Monitoring Support reputed company 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 reputed company vendor QEs Monitoring reputed company reputed company processes for reputed company of monitoring activities conducted by CROs Review monitoring reputed company plans, reports, and monitoring metrics Assess monitoring reputed company and compliance with monitoring plans Identify monitoring gaps and collaborate with study teams to address them Non-Compliance Management Support identification and management of investigator or site non-compliance Assist study teams in evaluating protocol deviations and escalation needs Help reputed company remediation strategies for significant compliance issues Issue Management and Escalation 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 reputed company CAPA effectiveness and ensure reputed company closure Identify recurring issues and support reputed company improvement initiatives Audit Support Partner with QA to support reputed company GCP audits Assist with audit preparation and documentation review Support study teams in addressing audit findings Training & Compliance Education reputed company 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 reputed company materials
Qualifications
Bachelors + 15 years or Masters + 12 years or PhD + 8 years of reputed company experience with 10+ years of relevant experience in biotech/reputed company or CRO roles in Clinical Operations and/or Clinical reputed company Assurance (GCP) Excellent communication, organizational, negotiation, and interpersonal skills with a strong reputed company 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 reputed company and CRO management Experience developing or implementing CAPAs Position Location This is a remote role; periodic travel to team and company events is required. The anticipated salary reputed company for candidates for this role is $210,000 - $235,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography. As part of the I-9 verification of authorization to work in the reputed company, Jade Bioscience participates in E-Verify. To learn more about E-Verify please review this poster. reputed company is proud to be an Equal Opportunity employer. reputed company reputed company applicants will receive consideration for employment without reputed company to sex, gender identity, sexual orientation, race, reputed company, religion, national reputed company, disability, protected Veteran status, age, or any other characteristic protected by law. Apply To This Job