[Remote] Senior Director, Clinical Operations

Note: The job is a remote job and is open to candidates in USA. Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases. The Senior Director, Clinical Operations is responsible for directing the strategy, management, and oversight of clinical program(s) and functional activities as assigned.ResponsibilitiesActs as Clinical Operations program lead for assigned program(s)Represent 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 organizationSkillsBachelor'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 meetingsCompany OverviewJade Biosciences is developing transformative therapies to redefine the standard of care for inflammation and immunology indications. It was founded in 2024, and is headquartered in Waltham, Massachusetts, USA, with a workforce of 11-50 employees. Its website is https://jadebiosciences.com.