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Director, Clinical Compliance

$210k-235k/hr•Full-timeRemote

location_onTerrace Street, West Edge, First Hill, Seattle, King County, Washington, 98104, United States

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Job Description

About Jade Biosciences

Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade’s lead candidate, JADE101, targets the cytokine APRIL, 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 well as JADE301, an undisclosed antibody candidate, both currently in preclinical development.

Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount. For more information, visit Jade Biosciences is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Work location

Work model: Remote

Terrace Street, West Edge, First Hill, Seattle, King County, Washington, 98104, United States

Seattle, Washington

Open in Google Maps(47.60181, -122.32900)

Key Responsibilities

  • check_circleAnalyze compliance metrics and audit findings to identify systemic risks
  • check_circleDrive initiatives to ensure continuous inspection readiness across clinical studies
  • check_circleAssist in preparation for regulatory inspections and internal audits
  • check_circleSupport oversight of CROs and clinical vendors to ensure compliance
  • check_circleDevelop processes for oversight of monitoring activities
  • check_circleSupport identification and management of
  • check_circleDrive development and implementation of CAPAs from audits
  • check_circleProvide training to clinical teams on ICH-GCP and regulatory requirements
  • check_circleServe as GCP compliance advisor to study teams to promote quality culture

Requirements

  • verifiedBachelors + 15 years or Masters + 12 years or PhD + 8 years of related experience
  • verified10+ years of relevant experience in biotech/pharma or CRO roles in Clinical Operations and/or Clinical Quality Assurance (GCP)
  • verifiedExperience managing, coaching, and mentoring personnel
  • verifiedExperience supporting global clinical trials in sponsor or CRO environments
  • verifiedStrong working knowledge of ICH-GCP and global regulatory requirements
  • verifiedExperience supporting GCP audits or regulatory inspections
  • verifiedExperience with vendor oversight and CRO management

Skills, education and keywords

Skills: ich-gcp, gcp, capa, vendor oversight, monitoring oversight, audit preparation, inspection readiness, protocol deviations, quality assurance.

Education: Bachelor's degree with 15 years of experience; Master's degree with 12 years of experience; PhD, .

Frequently asked questions about Director, Clinical Compliance at Jade Biosciences

What does a Director, Clinical Compliance at Jade Biosciences do?expand_more
A Director, Clinical Compliance at Jade Biosciences is responsible for the following: Analyze compliance metrics and audit findings to identify systemic risks; Drive initiatives to ensure continuous inspection readiness across clinical studies; Assist in preparation for regulatory inspections and internal audits; and Support oversight of CROs and clinical vendors to ensure compliance.
What are the requirements for this Director, Clinical Compliance role?expand_more
Jade Biosciences is looking for candidates who meet the following requirements: Bachelors + 15 years or Masters + 12 years or PhD + 8 years of related experience; 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; and Experience supporting GCP audits or regulatory inspections.
What is the salary range for Director, Clinical Compliance at Jade Biosciences?expand_more
The advertised salary range for Director, Clinical Compliance at Jade Biosciences is $210k-235k/hr.
Where is the Director, Clinical Compliance role at Jade Biosciences located?expand_more
Director, Clinical Compliance at Jade Biosciences is based in Terrace Street, West Edge, First Hill, Seattle, King County, Washington, 98104, United States. This is a remote role.
Is this Director, Clinical Compliance job remote, hybrid, or on-site?expand_more
Jade Biosciences has listed this Director, Clinical Compliance role as remote.
How much experience is required for this Director, Clinical Compliance role?expand_more
Director, Clinical Compliance at Jade Biosciences typically requires 8+ years of relevant experience at the executive level.
What skills do you need for the Director, Clinical Compliance role at Jade Biosciences?expand_more
Key skills for Director, Clinical Compliance at Jade Biosciences include ich-gcp; gcp; capa; vendor oversight; monitoring oversight; audit preparation; inspection readiness; and protocol deviations.
What education is required for Director, Clinical Compliance at Jade Biosciences?expand_more
Educational requirements for this role: Bachelor's degree with 15 years of experience; Master's degree with 12 years of experience; and PhD, .
What category does the Director, Clinical Compliance role belong to?expand_more
Director, Clinical Compliance at Jade Biosciences is part of the Healthcare & Nursing job category on Recrutus.