Director, Clinical Operations

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 Director, Clinical Operations will oversee the strategic and operational execution of clinical trials, leading cross-functional teams and collaborating with internal stakeholders and external vendors. This individual will manage trial budgets, vendor selection, and risk mitigation while contributing technical input to key clinical documents. This individual will also mentor staff, foster strong team and cross-functional relationships, and nimbly adapt in our dynamic organization. With proven leadership, financial acumen, and problem-solving skills, this individual will thrive in Jade’s dynamic environment and evolve to support broader corporate initiatives. This is an exciting opportunity to make significant contributions to Jade’s immunology pipeline, leading trials from first in human single site to global (APAC, LATAM, etc.) phase 3, as assigned.

Key Responsibilities

• Performs role of Clinical Operations trial lead for assigned trials and leads cross-functional Study Execution Teams
• Develops and executes trial operational strategies and partners cross-functionally to drive trial execution forward; provides strategic and technical recommendations to senior leadership
• Directs the selection of CROs and other vendors (IxRS, Central Lab, ancillary/tech vendors), directs development of vendor Scopes of Work (SOW), scope changes, budgets, and vendor payments and partners with CROs and other vendors to deliver on study execution
• Creates and tracks clinical trial budgets
• Directs risk mitigation, escalation, and resolution activities both internally and with sites and vendors
• Directs technical and strategic input into the development of clinical documents (protocols, monitoring plans, informed consent forms, investigator brochures, clinical study reports)
• Builds relationships with clinical sites, vendors, and key stakeholders and maintains an understanding of the external landscape and adjusts plans accordingly
• Represents Clinical Operations in cross-functional activities and supports development and management of the Clinical Operations function
• Mentors more junior team members such as Clinical Trial Associates
• Effectively builds strong internal teams and cross-functional relationships and demonstrates leadership and team building skills, along with success in proactive risk mitigation and problem solving
• Flexible and creative in meeting the needs and challenges of a growing, dynamic company and demonstrates excellent problem-solving abilities
• Strong financial acumen with outstanding track record of building budgets and managing expenses to budget
• Contributes to corporate activities, including preparation of materials for Executive Team and Board of Director meeting materials
  
  

Qualifications

• Bachelors 15 years of related experience, or Masters 12 years of related experience
• 10 years of clinical research experience, including 7 years of trial management within a biopharmaceutical company; 5 years within a small/startup company is a plus
• Exceptional clinical trial management skills with a focus on strategic oversight of trial execution on time and on budget, study coordinator and/or site monitoring experience a plus
• Extensive phase 1 through phase 3, global trial management experience
• Immunology and/or rare disease trial management experience
• Extensive experience selecting and managing vendors, including CROs, labs, IxRS, EDC, and ancillary technology/applications (e.g. eDiaries, eConsent, apps, etc)
• Thorough knowledge and understanding of FDA and ICH Guidelines, GCP, medical terminology, and clinical trials
• Detailed understanding of all aspects of clinical protocol design, implementation, IND/BLA/NDA submissions, and overall drug development
• Experience managing, coaching, and mentoring personnel
• Excellent communication, organizational, negotiation, and interpersonal skills with a strong reputation for collaboration
  
  

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 $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 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.