Clinical Operations Director

Company Background

Tessa Therapeutics is a clinical stage biopharmaceutical company with the scientific vision of revolutionizing the treatment of cancer by redirecting the body’s potent anti-viral immune response to recognize and kill cancer cells. Tessa’s core virus-specific T Cell (VST) platform has shown compelling results in the treatment of solid tumors, and the company is building a portfolio of therapies addressing a wide range of tumors by combining the qualities of its T cell platform with complementary technologies. Tessa’s lead Phase III trial for nasopharyngeal carcinoma (NPC) is the world’s largest Phase III T cell immunotherapy trial for any cancer indication. The company has built up robust operational and supply chain capabilities to successfully deliver autologous T cell therapy treatments to a large patient pool across five countries. The combination of technologies from its academic, clinical, and commercial research partners have enabled the company to create a fully-integrated approach to the treatment of cancer with immunotherapy.

Our mission is to cure cancers and save lives with our innovative and widely accessible immunotherapies.

We are looking for highly motivated and enthusiastic individuals who are interested to be part of our Clinical Operations Team.

 

Job Position
Clinical Operations Director

Reports to
Chief Operating Officer

Overview of the role

This individual will be accountable for the planning and executing the mission and strategy for the Clinical Operations function. The incumbent will be responsible for overseeing clinical operation processes and systems, training programs, and implementing appropriate standard processes and operating procedures (SOPs) to ensure GCP compliance and inspection readiness within Clinical Operations. The Director may also sponsor and/or lead key strategic Clinical Operations organizational initiatives.

The Clinical Operations Director will work closely with multi-disciplinary departments and will require a solid understanding of the clinical trial lifecycle management such as study startup, feasibility, patient recruitment, project management, trial quality and data management.

Job Description

  • Leads the creation, deployment, and management of Clinical Operations’ systems, process and procedures, training programs, GCP compliance, and regulatory inspection-readiness activities.
  • Direct clinical operations activities including developing the clinical research strategy, investigator and site selection, interim and final analyses, qualification of CROs and evaluating their performance.
  • Develop and monitor Key Performance Indicators (KPIs) to track the progress of the ongoing clinical trials
  • Ensure alignment of activities/decisions affecting all trials within the clinical development pipeline
  • Develop and maintain departmental standard operating procedures (SOPs) in collaboration with Clinical Development, Regulatory Affairs and Quality Assurance
  • Oversight to ensure timely and appropriate response and resolution to study management issues
  • Prepare communication and status reports to provide updates/information to senior management
  • Actively participate in strategic planning activities including department budgeting and resource management
  • Manage strategic partners, supervise and mentor direct and indirect reports to assure performance and progress on assigned projects as appropriate

Qualification(s):

  • Strong working knowledge and interpretation of FDA and ICH – GCP regulations and guidelines.
  • Bachelor’s Degree or Graduate Degree in a field of science or nursing, preferably biology, chemistry, pharmacy, or other field related to human study
  • Broad and direct experience with regulatory authority inspections, including FDA inspections
  • More than 10 years of experience working in clinical trial operations and project management, with experience from Sponsor’s company
  • Extensive experience in oncology drug development, experience in immuno-oncology an added advantage