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Jade Biosciences · 9 hours ago

Director, Clinical Operations

Seattle, WA

Full-time

Hybrid

Director/Executive

$210K/yr - $235K/yr

12+ years exp

Jade Biosciences is focused on developing innovative therapies for autoimmune diseases. The Director, Clinical Operations will oversee clinical trials, manage trial budgets, collaborate with vendors, and provide strategic input to clinical documents while mentoring staff and adapting to the dynamic environment of the organization.

Health CareTherapeutics

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

Qualification

Clinical trial managementVendor managementImmunology experienceBudget managementFDAICH GuidelinesDrug development knowledgeCross-functional collaborationLeadership skillsProblem-solving skillsCommunication skillsOrganizational skillsNegotiation skillsInterpersonal skills

Required

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