Director, Clinical Operations

🕒 July 29

🇺🇸 United States – Remote

💵 $215k - $240k / year

⏰ Full Time

🔴 Lead

🏥 Clinical Operations

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Jade Biosciences

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2024

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Jade Biosciences is a clinical-stage biotechnology company developing potentially best-in-class therapies aimed at transforming the standard of care for autoimmune diseases. Its lead candidate, JADE101, is an antibody designed to inhibit the cytokine APRIL (A PRoliferation-Inducing Ligand) and is being developed for the treatment of immunoglobulin A nephropathy (IgAN). The company builds its pipeline from discovery-stage assets licensed from Paragon Therapeutics and is focused on advancing clinical programs to deliver new treatments for patients with autoimmune conditions.

📋 Description

• 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.

🎯 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.

🏖️ Benefits

• Health insurance • 401(k) matching • Paid time off • Remote work opportunities