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上海, 臨床及註冊 | 2023-02-14

Associate Director, Clinical Research Physician

Job Title: Associate Director, Clinical Research Physician
Location: Shanghai

 

Primary Function

  • Be responsible for the strategy and clinical development of clinical development line function by managing a group clinical research physician(s)
  • Take lead in Clinical Development Activities related to products, protocols or studies, timeline and budget
  • Provide leadership on project teams as clinical project leader
  • Serve as a scientific, medical accountable person for quality and timely delivery
  • As the primary development physician, represent the company while interacting with health authorities

 

Major Responsibilities, And Duties

  • Manage and train clinical project leader(s) and clinical research physicians
  • Establish and maintain liaisons with KoLs and principal investigators
  • Accountable for clinical and regulatory documents; ensure clinical trial design is scientific sound as well regulatory viable
  • Ensure high quality and completeness of clinical and regulatory documents, including but not limited to clinical study protocol, scientific paper publication, clinical study report, etc. Ensure project timelines are met.
  • Responsible for managing study and program costs/timelines against agreed-upon plans
  • Provide scientific/strategic input to licensing and business development opportunities, including early phase development aspects
  • Completes tasks in support of these activities as necessary, such as developing internal and external briefing documents, and other such activities requiring relevant technical expertise and clinical development experience
  • Supervise and lead the study conduct and assure that results meet the high standards of quality
  • Serve as a key knowledge source for internal stakeholders including Country Medical.
  • Represent the client through contact with Health authorities, KOL, Universities, and CROs

 

Qualifications

  • A MD level is mandatory
  • At least 5-year experience in oncology clinical development
  • Must have experience and/or solid understanding of all levels of clinical development (Phase I-IV)
  • Must have experience with the planning and execution of strategies for drug product registration, development and life-cycle management
  • Demonstrated ability to understand and manage, with appropriate support, the resources, time, and budgets for assigned projects
  • Ability to develop network internally and externally to effective communicate in situations requiring special tact and diplomacy
  • Excellent English (writing and speaking) and excellent mastery of English medical terminology