Pre-clinical & Clinical Project Manager

  • Full Time
  • Taipei

Website HanchorBio Inc.

HanchorBio Inc. - Chinese Antibody Society Career Center

Job Responsibilities

  • Manage projects timeline and budget from research, toxicology studies, IND filing to early-stage clinical
  • Develop and maintain detailed target product profiles (TPPs), project plans and risk & mitigation plans
  • Coordinate with cross-functional teams to drive project timeline, organize/ lead project meetings, and track action items until resolution
  • Evaluate, negotiate, execute, and coordinate all outsourced activities including but not limited to vendors, CROs, and CDMOs
  • Collaborate with consultants for clinical and regulatory activities, including communication with regulatory agencies, clinical sites etc.

 

Job Requirements

  • Master’s Degree in life sciences, nursing, pharmacy or equivalent (Ph.D. Degree is highly preferred)
  • More than six years of related preclinical and/or clinical experience of biologics in the biotechnology/pharmaceutical industry
  • In-depth knowledge of pharmaceutical development and clinical development
  • Experience in project management and clinical/regulatory affairs
  • Proficient in the Microsoft suite of business software including MS Projects and Access and other clinical/regulatory softwares
  • Evidence of building relationships with and managing expectations of stakeholders at all levels and externally, to persuade on business benefits and gain acceptance to changes
  • Excellent written and oral communication, collaboration and “think-out-of-the box” problem-solving skills; performance-driven, reliable team player with strong sense of responsibility
  • Comfortable meeting deadline in a fast-paced biotech environment
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