(Sr) Study Physician

Job description

JOB DESCRIPTION:

Core Role Responsibilities:

Local China clinical studies

• Act as the Study physician to the assigned studies - giving clinical leadership to the country studies to ensure the clinical quality of the study, alongside the Clinical DevOps team project leadership
• Guide and advise on the analysis of the studies in the projects; maintains an up-to-date repository of clinical information on projects, competitors, and the TAs in general;
• Lead the interactions with opinion leaders to collect their input as needed for the clinical project.
• Interacts with the Project Teams including Commercial, Regulatory Affairs, and other disciplines to ensure that the clinical project fulfills the regulatory requirements and represents the company to the Regulatory bodies as appropriate on clinical matters.
• Acquire and share clinical medical expertise in the therapeutic area and on the competitive treatments to support Clinical Operations, Medical Services, Marketing, Licensing & Acquisitions and Training teams.
• Perform other duties as assigned or requested

Regional/Global clinical studies

• Act as local clinical lead for the local China execution of the assigned studies in collaboration with the Regional/Global leads
• Provide clinical expertise to the Local/Regional/Global study team to ensure the clinical quality of the study execution in China
• Provide support into the data management, analysis and validation on study clinical information as requested by the study team
• Lead the interactions with Chinese opinion leaders in collaboration with the Regional/Global Study physicians/ Clinical Directors to collect their input as needed for the clinical project.
• Interacts with the Project Teams including Commercial, Regulatory Affairs, and other disciplines to ensure that the clinical project fulfills the regulatory requirements and represents the company to the Regulatory bodies as appropriate on clinical matters.
• Perform other duties as assigned or requested

Requirements:

• Education:
  • MD or PhD or MD/PHD and demonstrated ability to lead clinical programs. MD's are preferred when patient safety is a major part of the work. PhD in biological/pharmaceutical/chemical sciences or comparable level.
  • Expertise in relevant therapeutic areas (cardiology, diabetes, woman's health) is a plus

• Experiences:
  • 5 years of experience in the pharmaceutical industry as Clinical Research physician or Medical Affairs.
  • Experience in early clinical development projects and multinational settings is a plus

• Language Skills：
  • Chinese (professional working proficiency)
  • English (professional working proficiency)

• Mobility: frequent travels required
• Certificate Required: ICH-GCP certification
• Other Special requirement:
  • Effective and adaptable team player intra and inter functions
  • Effective and diplomatic communicator
  • Strong and flexible problem solver
  • Familiar with Clinical Study support tools and technology utilizations

• Competencies:
  • Good organizational skills
  • Good interpersonal skills
  • Assertive
  • Detail-oriented
  • Adaptable to changes

JOB FAMILY:

DIVISION:

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