Full Time

Director, Clinical Operations

Posted 1 month ago
Houston, Texas
Application ends: 31 May 2024
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Job Description

Global Life Science Hub is proud to partner with a cutting-edge biotech company dedicated to revolutionizing cancer treatment through innovative gene therapy modalities. The company leverages advanced technologies such as predictive analytics, machine learning, and artificial intelligence to identify highly expressed genes.

Following huge success in the enrolment of their first phase I study, their stock is reflected in their continued success and is currently trading at a staggering 300% this year leading to the appointment of a new Director of Clinical Operations and will play a critical role in the transformation in bringing all their clinical activities in-house.

Position: Director, Clinical Operations

Responsibilities:

  • Lead all aspects of clinical operations for early-phase development programs.
  • Develop and execute strategic plans for clinical trial implementation, ensuring alignment with corporate objectives and regulatory requirements.
  • Provide leadership and guidance to the clinical operations team, fostering a culture of excellence, innovation, and collaboration.
  • Direct and coordinate planning, initiation, execution, and closeout of clinical studies, including protocol development and site selection.
  • Ensure compliance with regulatory guidelines, industry standards, and Good Clinical Practice (GCP) throughout clinical trial conduct.
  • Collaborate with external vendors, central laboratories, and clinical sites to ensure timely and cost-effective trial execution.
  • Proactively identify and mitigate risks to study timelines, budget, and quality, implementing corrective actions as needed.
  • Oversee data management and monitoring activities to ensure the accuracy, completeness, and integrity of clinical trial data.
  • Work closely with other functional areas to drive integrated development strategies and achieve program milestones.
  • Lead process optimization initiatives to enhance the efficiency and effectiveness of clinical operations processes.
  • Build and develop the infrastructure of an in-house clinical operations team, including hiring, training, and mentoring staff.

Experience/Qualifications:

  • Minimum Bachelor’s degree in life sciences or related field, Master’s degree preferred.
  • 8-10 years of progressive clinical operations experience in the biopharmaceutical or biotechnology industry.
  • In-depth knowledge of immunology, particularly in cancer biology and T-cell therapy.
  • Strong understanding of global regulatory requirements, FDA and EMA regulations.
  • Proven leadership skills, ability to motivate cross-functional teams in dynamic environment.
  • Strategic planning and decision-making abilities, translating scientific concepts into actionable plans.
  • Strong analytical and problem-solving skills, ability to drive decisions in a timely manner.
  • Collaborative and inclusive leadership style, focused on building strong relationships and fostering teamwork.

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