Clinical Operations Director

2 months ago


Texas, United States CARsgen Therapeutics Full time
Job Description

**Clinical Operations Director**

We are seeking a highly experienced Clinical Operations Director to join our team at CARsgen Therapeutics. As a key member of our clinical operations team, you will be responsible for ensuring the successful execution of clinical trials.

Key Responsibilities

  • Ensure Clinical Trial Compliance: Develop and implement strategies to ensure clinical trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and company standards.
  • Develop and Implement Operational Infrastructure: Design and implement scalable infrastructure to support clinical trial operations, with a focus on harmonized processes and excellence in study management.
  • Contribute to SOP Development: Collaborate with cross-functional teams to develop and implement internal SOPs and clinical work practice documents, ensuring compliance with FDA and EMA regulations.
  • Communicate Clinical Trial Updates: Effectively communicate clinical trial updates to executive leadership and other functional groups.
  • Resource and Cost Efficiency Analysis: Conduct strategic analysis of resource allocation, utilization, and cost efficiency across all clinical trials, identifying opportunities to enhance efficiency while maintaining or improving quality.
  • Leadership and Supervision: Provide direction and leadership to clinical project managers, supervise personnel as needed, and serve as the escalation point for clinical project managers.
  • Vendor Management: Develop and implement strategies for CRO and vendor selection and management.
  • Resource Allocation: Approve and allocate clinical operations resources based on business priorities.
  • Cross-Functional Collaboration: Work collaboratively with cross-functional personnel to accomplish agreed-upon deliverables.

Qualifications

  • Education: Bachelor's and/or master's degree in sciences, health, or related area. Advanced degree is preferred.
  • Experience: 10+ years of pharmaceutical or biotech-related/clinical research experience. Oncology/immuno-oncology experience is required.
  • Leadership Skills: Strong leadership skills, with at least 8 years of management experience.
  • Communication Skills: Exceptional written and verbal communication skills.
  • Regulatory Knowledge: Working knowledge of FDA regulations, GCP, ICH guidelines, and clinical research SOPs.
  • Vendor Management: Demonstrated capability to proactively manage vendor-supplied resources.
  • Stakeholder Interaction: Experience interacting with internal and external stakeholders.


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