Director, Clinical Operations

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  JadeBiosciences.com  and follow the Company 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. Th is 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, th is  individual  will  thrive in  Jade’s  dynamic environment and  evolve to s upport 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 $215,000 -  $240,000 . 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.