Senior Director, Clinical Operations Boston; Chicago; San Francisco; Seattle

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.Role OverviewThe Senior Director, Clinical Operations is responsible for directing the strategy, management, and oversight of clinical program(s) and functional activities as assigned.Key ResponsibilitiesActs as Clinical Operations program lead for assigned program(s)Represents Clinical Operations at the Clinical Development Team and /or Global Program TeamDevelops and executes program operational strategyPartners closely and effectively with other functions and functional heads to drive program forwardProvides strategic and technical recommendations to senior leadershipDirects the selection of CROs and other vendors (IxRS, Central Lab, ancillary/tech vendors)Acts as an escalation point for CRO/vendor issuesDirects development of vendor Scopes of Work (SOW), scope changes, budgets, and vendor paymentsPartners with CRO and other vendors to deliver on study executionCreates and tracks clinical program budgetsDirects risk mitigation, escalation, and resolution activities both internally as well as with sites and vendorsDirects technical and strategic input into the development of clinical documents (protocols, monitoring plans, informed consent forms, investigator brochures, clinical study reports, etc.)Builds relationships with clinical sites, vendors, and key stakeholdersMaintains understanding of external landscape and adjusts plans accordinglyRepresents Clinical Operations in cross-functional activities as assignedPlays a key role in the development and management of the Clinical Operations function; may act as a deputy for the Head of Clinical Operations as assignedHires, manages, coaches, and mentors staffContributes to building the organizationQualificationsBachelor's degree in a related field required, an advanced degree is a plus17+ years of clinical research experience, including 10+ years of trial and/or program-level management within a biopharmaceutical company, and 3+ years of line management experienceExceptional clinical trial & program management skills with a focus on strategic oversight of program execution on time and on budgetExtensive 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 trialsDetailed understanding of all aspects of clinical protocol design, implementation, IND/BLA/NDA submissions, and overall drug developmentExperience managing, coaching, and mentoring personnelExcellent communication, organizational, negotiation, and interpersonal skills with a strong reputation for collaborationAble to drive decisions forward in times of ambiguity or with incomplete informationEffective in promoting and maintaining productive internal and external relationshipsProven leadership and team-building skills, along with success in proactive risk mitigation and problem solvingFlexible and creative to meet the needs and challenges of a growing, dynamic companyDemonstrated problem-solving abilitiesProven ability to influence up, down, and across the organizationStrong financial acumen with outstanding track record of building budgets and managing expenses to budgetStudy coordinator and/or site monitoring experience a plusThrives in a small company environment, where day-to-day duties go above and beyond this job descriptionMay contribute to corporate activities, e.g., preparation for Board of Director meetingsPosition LocationThis is a remote role; periodic travel to team and company events is required.The anticipated salary range for candidates for this role is $255,000 – $280,000. The final salary offered will depend on several factors, which may include, but is 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 Biosciences participates in E-Verify. To learn more about E-Verify, please review the 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.J-18808-Ljbffr