Position Statement

  • Represent the clinical biomarker group at global and China project team.
  • Accountable and responsible for the Clinical Pharmacology support for the assigned projects.
  • Responsible for developing clinical biomarker implementation strategies that are aligned with central lab operation, clinical operation, clinical medical development, clinical pharmacology and preclinical translational research.
  • Responsible for biomarker strategy development and data analysis in clinical trials.
  • Responsible for summarizing and interpreting results of pharmacokinetic, pharmacodynamic analyses with respect to their impact on development and clinical use of drugs.

Job Requirements

  • PhD in one of the Life Science areas (Molecular & Cellular Biology, Biochemistry, Immunology etc) required.
  • 2-3 years’ experience in clinical biomarkers and translational researches in a pharmaceutical company or biotech industry (Oncology, Immunology or hematology) is a must.
  • Understanding of clinical drug development strategies is preferred.
  • Understanding of the operational considerations in executing biomarker strategies in clinical development is preferred.
  • Enjoys working with other people within an international Team and in a dynamic environment.
  • Bilingual with English and Chinese proficiency.
  • Ability to work in a matrix, project-oriented environment.

Position Statement

Executive Management

  • Serve as a key and active member of senior management teams, interacting to ensure business objectives are aligned and that the company is performing to operational objectives.
  • Coach and mentor the Quality and Regulatory organizations ensuring appropriate levels of accountability for decision making and clearly communicate cross-functionally within the organization.

Quality

  • Responsible for company’s product quality and reliability to meet or exceed regulatory.
  • Responsible for company’s Quality Compliance to ensure compliance with regulatory agencies and all applicable standards.
  • Develop and execute quality design and quality assurance strategy for new product development and sustaining business activities.
  • In support of the quality system, provide effective leadership support, training and guidance to all company personnel.

Regulatory Affairs

  • Provide management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to gain product approvals.
  • Provide counsel, training and interpretation of FDA, CFDA and other regulatory requirements to all company personnel.
  • Oversee preparation and filing of all regulatory documents with the FDA,CFDA and other regulatory agencies.
  • Develop and maintain external relationships with key opinion leaders and regulatory officials.
  • Direct the development of systems, practices and processes to ensure effective ongoing review of product design and/or manufacturing changes and adverse events.
  • Provide leadership and direction for significant deviation events that may impact compliance status or represent the significant business risk.