Associate Director, Clinical Documentation

About Jade Biosciences 

Jade Biosciences is focused on developing innovative, best-in-class therapies to address critical unmet needs in autoimmune diseases. Our lead candidate, JADE101, is designed to inhibit the cytokine APRIL (A Proliferation-Inducing Ligand) and is being developed for the treatment of immunoglobulin A nephropathy (IgAN), a chronic kidney disease that can impair kidney function over time. JADE101 aims to reduce harmful IgA antibodies, lower proteinuria (a key marker of kidney damage), and preserve long-term kidney function. A Phase 1 healthy-volunteer study of JADE101 is ongoing, with interim, biomarker-rich data expected in the first half of 2026. Jade’s pipeline also includes a second development candidate, JADE201, and an undisclosed antibody discovery program, JADE-003, both currently in preclinical development. For more information, visit JadeBiosciences.com and follow us on LinkedIn. 

Role Overview 

The Associate Director, Clinical Documentation will be responsible for managing the Trials Master File(s) and other essential clinical documentation generated during the conduct of Jade’s clinical trials. This individual will bring expertise in clinical documentation systems and expertise in building processes from the ground up. Ensuring inspection readiness and regulatory compliance will be central to the role.

This is an exciting opportunity to make important contributions at Jade by leading and implementing crucial document management strategies.

Key Responsibilities 

• Effectively partner with Clinical Operations, Quality, Regulatory, and external vendors to ensure document completeness, accuracy, and inspection readiness.
• Develop and implement clinical documentation management processes, SOPs, and best practices.
• Establish, maintain, and oversee the electronic Trial Master File (eTMF) in compliance with ICH-GCP, FDA, and other applicable regulations.
• Ensure timely collection, review, and quality control (QC) of essential documents throughout the lifecycle of clinical trials.
• Act as the point of contact for clinical documentation during audits and regulatory inspections.
• Support system selection, configuration, and implementation of an eTMF platform if not already established.
• Provide oversight of CROs, vendors, and sites regarding documentation deliverables.

Qualifications 

• Bachelor’s degree + 13 years of related experience, or master’s degree + 10 years of related experience
• 5+ years of experience in clinical documentation management or TMF operations within the biotech/pharmaceutical industry.
• Strong knowledge of ICH-GCP and regulatory requirements related to clinical documentation.
• Hands-on experience with electronic TMF systems.
• Experience leading TMF vendor oversight.
• Excellent organizational, communication, and project management skills.
• Ability to work independently in a fast-paced, small-company environment.

Position Location 

This is a remote role; periodic travel to team and company events is required. 

The anticipated salary range for candidates for this role is $170,000-$190,000. 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 United States, Jade Bioscience participates in E-Verify. To learn more about E-Verify please review this poster.

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.