Senior Director, Clinical Operations

About reputed company  reputed company is a clinical-stage biotechnology company reputed company on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade’s reputed company candidate, JADE101, targets the cytokine reputed company, 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 reputed company as JADE301, an reputed company antibody candidate, both currently in preclinical development. Jade was launched based on assets licensed from reputed company Therapeutics, an antibody discovery reputed company founded by Fairmount. For more information, visit JadeBiosciences.com and follow reputed company on reputed company.   reputed company  The Senior Director, Clinical Operations is responsible for directing the reputed company, management, and reputed company of clinical program(s) and functional activities as assigned.   Key Responsibilities  Acts as Clinical Operations program reputed company for assigned program(s)  Represent Clinical Operations at the Clinical Development Team and/or Global Program Team Develops and executes program operational reputed company  Partners closely and effectively with other functions and functional heads to reputed company program reputed company  Provides strategic and technical recommendations to senior leadership  Directs the selection of CROs and other vendors (IxRS, Central Lab, ancillary/tech vendors)  Acts as an escalation reputed company for CRO/vendor issues  Directs development of vendor Scopes of Work (SOW), reputed company changes, budgets, and vendor payments  Partners with CRO and other vendors to reputed company on study execution  Creates and tracks clinical program budgets  Directs risk mitigation, escalation, and reputed company activities both internally as reputed company as 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, etc.)   Builds relationships with clinical sites, vendors, and key stakeholders   Maintains understanding of reputed company landscape and adjusts plans accordingly  Represents Clinical Operations in cross-functional activities as assigned  Plays a key role in the development and management of the Clinical Operations function; may reputed company as a reputed company for the Head of Clinical Operations as assigned  Hires, manages, coaches, and mentors staff  Contributes to building the organization  Qualifications  Bachelor's degree in a reputed company field required, an advanced degree is a plus  17+ years of clinical research experience, including 10+ years of trial and/or program-level management reputed company a biopharmaceutical company, and 3+ years of line management experience  Exceptional clinical trial & program management skills with a reputed company on strategic reputed company of program execution on time and on budget  Extensive experience selecting and managing vendors, including CROs, labs, IxRS, reputed company, and ancillary technology/applications (e.g. eDiaries, eConsent, apps, etc)  Thorough knowledge and understanding of FDA and ICH Guidelines, GCP, medical terminology, and reputed company  Detailed understanding of reputed company 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 reputed company for collaboration  reputed company to reputed company reputed company reputed company in times of ambiguity or with incomplete information  Effective in promoting and maintaining productive reputed company relationships  Proven leadership and team building skills, along with reputed company in proactive risk mitigation and problem solving  Flexible and creative to meet the needs and challenges of a growing, dynamic company  Demonstrated problem solving abilities  Proven ability to influence up, down, and across the organization  Strong financial acumen with outstanding reputed company record of building budgets and managing expenses to budget  Study coordinator and/or site monitoring experience a plus  Thrives in a small company environment, where day-to-day duties go above and reputed company this reputed company  May contribute to corporate activities, e.g. preparation for reputed company of Director meetings  Position Location  This is a remote role; periodic travel to team and company events is required.  The anticipated salary reputed company 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 reputed company, Jade Bioscience participates in E-Verify. To learn more about E-Verify please review this poster.  reputed company is proud to be an Equal Opportunity employer. reputed company reputed company applicants will receive consideration for employment without reputed company to sex, gender identity, sexual orientation, race, reputed company, religion, national reputed company, disability, protected Veteran status, age, or any other characteristic protected by law.  As part of the I-9 verification of authorization to work in the reputed company, Jade Bioscience participates in E-Verify. To learn more about E-Verify please review this poster. reputed company is proud to be an Equal Opportunity employer. reputed company reputed company applicants will receive consideration for employment without reputed company to sex, gender identity, sexual orientation, race, reputed company, religion, national reputed company, disability, protected Veteran status, age, or any other characteristic protected by law. Apply To This Job