Pl - Associate Director, Clinical Research

Merck Merck · Pharma · Beijing, China

Project lead for early clinical research in China for GYN programs, focusing on developing products towards registration, engaging KOLs, and preparing for regulatory submission.

What you'd actually do

  1. Provide leadership and experience in conducting early clinical research in China.
  2. Drive assigned program(s) for developing products towards registration.
  3. Develop study protocol.
  4. Engage key opinion leaders.
  5. Draft study report.
  6. Prepare dossier for regulatory submission.

Skills

Required

  • PHD/Master in clinical medicine
  • postgraduate training in oncology or relative major
  • Deep understanding of China regulatory environment and clinical development procedure
  • Previous experience of clinical research/clinical development
  • strategy development
  • medical monitoring
  • protocol/ writing
  • strong leadership
  • excellent written and oral communication skills
  • project management skills
  • Strong capability of work prioritization
  • deliver results with parallel multiple tasks
  • Excellent language skills in both English and Chinese
  • Adaptability
  • Clinical Quality Management
  • Clinical Research
  • Clinical Study Design
  • Clinical Trial Planning
  • Clinical Trials
  • Clinical Trials Monitoring
  • Data Analysis
  • Healthcare Project Management
  • ICH GCP Guidelines
  • Investigation Procedures
  • Medical Research
  • Medical Writing
  • Process Improvements
  • Regulatory Compliance
  • Risk Management
  • Strategic Planning
  • Strategic Thinking
  • Team Leadership
  • Training and Development

What the JD emphasized

  • China regulatory environment
  • clinical development procedure
  • clinical research
  • clinical development