• , US

Company:  Confidential

Job Title: Director Clinical Operations – Oncology

Job Number: 79110

Location: , US

Job Description

Seeking a highly motivated Director, Clinical Operations to join a fast-paced, dynamic team during an exciting phase of the Clinical Development Program.

Responsibilities

* Oversee day-to-day operations of clinical trials, ensuring compliance with guidelines and regulations. * Develop and manage trial timelines, budgets, and resources. * Lead vendor selection and management processes, including oversight of external vendors. * Manage trial budgets, invoicing, and financial tracking. * Provide input into clinical documents and plans, escalate issues as needed. * Communicate updates to Senior Management and cross-functional teams. * Coordinate audit readiness and inspection activities, address noncompliance. * Develop relationships with Key Opinion Leaders. * Coach and guide Clinical Operations team, conduct performance reviews. * Train and mentor junior staff on GCP and ICH guidelines. * Maintain and review departmental SOPs for compliance. * Drive continuous improvement in clinical operations processes. * Act as a subject matter expert in operational standards and SOP development.

Required Skills

* BA/BS with 8+ years of clinical trial and program experience, including 4+ years in independent trial management. * Cell and Gene Therapy experience preferred; Oncology Phase 1-3 experience required. * Strong global drug development background. * Expertise in operational challenges like site activation, enrollment, monitoring, and compliance. * Collaborative skills with Regulatory, CMC, Biostatistics, and other functions. * Advanced knowledge of FDA, ICH, GCP regulations, and inspection/audit experience. * Excellent communication, leadership, problem-solving, and organizational skills. * Track record in team-building and relationship management. * Willingness to travel up to 20%. * Required 3 days onsite

Application Deadline: 2024-07-08

 

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