Director, Clinical Operations

Jade Biosciences • Boston, MA

82d • $210,000 - $235,000

About The Position

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.

Requirements

• 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

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

Benefits

• Remote work flexibility
• Periodic travel to team and company events required
• Salary range of $210,000 - $235,000 based on experience and qualifications

What This Job Offers

• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 11-50 employees