Company Description

Terns Pharmaceuticals is a global biotechnology company committed to discovering and developing molecularly-targeted, oral, small molecule medicines to treat liver disease and cancer.  Based in San Mateo and Shanghai, China, Terns Pharmaceuticals is focused on bringing forward innovative therapeutic candidates with the potential to address significant unmet medical needs in China and world-wide. The company combines expertise in disease biology and medicinal chemistry with a capital-efficient drug discovery model and extensive clinical development capabilities to advance its growing pipeline of medicines.

Position Overview

We are seeking a talented, experienced and highly motivated individual to advance the mission of Terns Pharmaceuticals as the global clinical operations lead for our portfolio of small molecule drug candidates for the treatment of non-alcoholic steatohepatitis (NASH) and oncology.  The successful candidate will be a responsible for leading and implementing operational aspects of Terns clinical studies and development strategies and engaging with project teams both in the US and China and senior management to advance our extensive pipeline.

Responsibilities:

  • Engage with senior management on the strategy for development of Terns’ NASH and oncology pipeline as the primary team member responsible for clinical trial execution
  • Lead all operational aspects of Terns’ global clinical trials, including protocol development and initiation; oversight of study management, data collection and data quality; study close-out activities; and timely deliverable of study data as well as implementation of corrective actions as necessary
  • Develop and manage clinical development timelines across projects; develop and manage clinical trial budgets
  • Independently represent clinical operations on project development team working with other functional leads to propose development strategies to senior management and oversee their implementation
  • Build Terns’ clinical operations team by anticipating and identifying resources necessary for implementation of clinical studies
  • Coordinate with scientific functions to operationalize collection of biomarker data in clinical studies and to assemble key study committees, such as DSMBs and adjudication committees
  • Drive selection and oversight of clinical development vendors
  • Coordinate timelines and resource planning across projects in clinical development and progress toward clinical development, manage the complexities of interdependent clinical development programs
  • Provide expertise on ICH/GCP guidance and local regulations to ensure compliance for clinical trial execution
  • Build Terns’ systems and processes for clinical development activities; develop and oversee standard operating procedures for conducting clinical trials and other clinical development processes
  • Identify and actively engage in the process of solving problems related to clinical development

Desired Skills and Experience:

  • At least 12 years of experience in operational roles at clinical stage pharmaceutical companies and/or CRO’s
  • Bachelors degree or higher
  • Extensive experience with CRO oversight for early phase and late phase global clinical trials conducted in multiple countries and continents
  • Ability to work at multiple levels, engaging with senior leadership on clinical development strategy as well as conducting study level work
  • Proven clinical operational leadership for portfolios consisting of multiple products within a therapeutic area
  • Experience in clinical operational roles for all phases of clinical studies (Phase 1, Phase 2 and Phase 3; post marketing study experience is advantageous but not required) and all clinical trial execution processes and plans, including prior experience with corrective actions
  • Extensive experience serving on and leading high functioning teams charged with developing clinical development strategies and executing on plans
  • Extensive leadership experience in clinical operations and managing team members working in clinical development operations roles, including contractors
  • Deep knowledge of ICH/GCP guidance
  • Experience developing standard operating procedures for clinical development activities
  • Track record of effectively resourcing development programs and clinical studies through outsourcing and use of contractors
  • Excellent English language written and oral communications skills