Medical director, Clinical development

BeiGene

Responsibilities:

  • Provide overall medical and safety oversight and monitoring of outsourced or in-house oncology clinical studies
  • Key contributor to study design and development of study protocol, IB, eCRF, ICF, SAP, and other study material
  • Key contributor to the development of study feasibility plan and questionnaire, analysis of feasibility results, and selection of study sites and investigators
  • Provides medical monitoring of ongoing studies, including eligibility review, responding to protocol questions by sites, IRB/EC and regulatory agencies, evaluation of AE, SAE and laboratory data to identify safety signals, review of medical history, concomitant diseases and medications, etc.
  • Draft and/or review Safety Management Plans, evaluate regulatory reporting requirements, generate and/or review notification letters to regulators, investigators, IRB/EC, summarize data for Safety Monitoring Committees, generate and/or review Annual Safety Reports, protocol deviations and correspondence to regulatory authorities, IRB/EC and investigators
  • Serve as internal pharmacovigilance expert and establish in-house safety systems including SOPs, safety database, tracking and reporting system
  • Review and analyze study results, generate presentations, publications and reports
  • Provides therapeutic training relevant to specific study to internal and CRO project team, attend and/or present at investigator and project team meetings
  • Develop and implement medical and protocol training for PM, CRA, and other clinical team members, may supervise and mentor junior medical staff

Requirements:

  • Clinical medicine bachelor degree above, oncology/hematology education or working experience is preferred, with pre-marketing oncology drug development experience
  • Have extensive pre-marketing oncology drug development experience, including phase 3
  • Experience writing clinical study protocols, IB, reports and other documents preferred
  • Knowledge of ICH GCP Guidelines and other regulatory policies governing clinical research
  • Ability to handle multiple competing priorities, excellent professional communication skills
  • Ability to lead by example and inspire team members
  • Self-motivated and energetic, proactive and organized with exceptional follow-up
  • Willing and able to learn quickly in a fast-paced environment, excellent team player with professionalism

To apply for this job email your details to hr@beigene.com

Apply using webmail: Gmail / AOL / Yahoo / Outlook