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- 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.
- 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.
- 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.
- 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.
- 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.