• Full Time (Salaried)
  • ,

Company:  Confidential

Job Title: Director Clinical Operations – Oncology

Job Number: 34883

Location:

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

 

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