Clinical Operation Director

3 weeks ago

Taipei, Taiwan Fyte Full time
General Statement:
The Clinical Operations Director is responsible for the leadership and oversight of development and implementation of clinical programs and pull-through projects. The position includes strategic input to company's assets, programs, and database development while working closely with clinical, business development, and other relevant departments. Provides leadership and strategic input to all clinical trial phases. Responsible for operational planning and resource management. Manages interface with vendors and countries. This individual is a manager of people and possesses strong people management skills. Acts as a scientific liaison between agencies, academic institutions, the pharmaceutical industry, and the company. Serves as an organization representative to outside contacts. Proactively manages risks and possesses contingency planning skills.

Responsibilities:
  • Provides strategic input to planning, design, development and interpretation of global clinical trials and research.
  • Develops scientific approaches for clinical protocols and related data collection activities. Provides direction on global clinical trials as required.
  • Ensures optimal resourcing across trials to meet business needs according to portfolio prioritization.
  • Leads the development of global clinical trial protocol by working closely with respective teams and translating the approved trial concept sheet into efficient, high quality, executable clinical protocols
  • Accountable for trial level life cycle budget management, internal and external resource allocation within assigned trials.
  • Manage interface with vendors and countries to ensure vendors meet quality standards; contribute to the development/amendment of vendor contracts
  • Reviews and/or prepares strategic input to reports prepared for submissions to FDA and other regulatory agencies.
  • Contributes to internal publication strategies through paper proposals, scientific writing and/or review.
  • Implement the strategic plan for our clinical projects, including database monitoring, trial results, clinical case and statistical evaluation and population management in support of clinical operations.
  • Develop and maintain relationships with academic institutions for the purposes of goodwill, business, and research collaboration.
  • Participate in strategic planning at the corporate level.
  • Support corporate counsel in risk management and contract evaluation. Proactively manages risks and possesses contingency planning skills.

Requirements:
  • MS or above degree in pharmaceutical, biology, or other related field preferred.
  • 15+ years' clinical trial management and operations, biotech research and drug development experience from pre-clinical through post-marketing study.
  • Extensive experience as scientific/technical experts, including presentations before USA, EMA, and other regulatory agencies, conferences, and academia.
  • Experience in strategic planning and collaboration with executives and key clinical, medical and operations teams.

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