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Job Details

Location
Shanghai
Salary
Competitive Salary
Job Type
Permanent
Ref
BH-19200
Contact
Richard Hao
Contact email
Email Richard
Posted
about 1 month ago
Shanghai, China
Industry: Pharmacy, Biotech
 

Job Description Summary:
 
We are a clinical-stage biotech organization in China, driven by our commitment to science and patient needs. Our mission is to discover, develop, and commercialize innovative, safe, affordable medicines, with a focus on endocrine, cardiovascular, and metabolic diseases, and women's health. We leverage internal R&D capabilities, external technology, and in-licensing to address unmet medical needs and build a patient-focused portfolio.
 

Primary Function/Purpose:

Be responsible for the design, implementation, monitoring, analysis, and reporting of clinical studies conducted in the early and late development stage with the medical contributions to the activities throughout the process from Investigational New Drug to New Drug Application as well as line extension based on the product lifecycle strategy.
 

Key Responsibilities:

Medical Research and Development Role:
  • Participate and lead strategic planning and implementation for products, including medical communication strategy;
  • Accountable for the clinical development strategy with corresponding molecule(s) from clinical perspective;
  • Design clinical development plan and study protocol for corresponding molecule(s) including early phase I, II and phase III clinical studies closely working with all members to be involved in clinical research, interact closely with PK, pharmacology and translational research/biomarker experts in the clinical studies preparation, conduction, result interpretation and IND/NDA/BLA activities, including but not limited to discussion of PK/PD relationships, dose selection and inclusion of biomarkers (disease as well as pathway or physiological biomarkers) etc.
  • Take medical lead in IND/NDA/BLA application. Collaborate with regulatory and other team to complete and submit regulatory filing and other regulatory documentation;
  • Evaluate opportunities and plan on corresponding molecule(s) for the clinical development;
  • Take medical lead in clinical trial team (CTT). Work with clinical operation, and other groups to develop/review/write/approve clinical science documents, including but not limited to Informed Consent Form, Case Report Form, Case Report Form instructions, data management relevant documents, SAP, MP, study risk management plan, drug supply plan, clinical pharmacology related activities (PK/PD report, modeling, simulation plans, etc.);
  • Take lead on study committee relevant tasks (steering committee, adjudication committee, safety monitoring committee, etc.);
  • Provide initial and ongoing medical trainings to operation teams and investigators to ensure the high standards of the clinical trials;
  • Ensure study quality during operation period, such as monitor and review critical data and process in clinical trials, including but not limited to identify and evaluate the protocol deviations;
  • Prepare or review the study reports and CTD for NDA/BLA and respond to authority’s inquiries in regard to medical related;
  • Prepare or review abstracts, posters, and content for scientific events in domestic and/or international academic platform, etc.;
  • Collaborate with pharmacovigilance to review safety data and provide medical support and judgment to ensure the high standards of clinical safety;

Other important Responsibilities:

  • Participate and support the research, in/out licensing of new targets or drugs in other therapeutic areas led by business development;
  • Interact with external experts from healthcare organization and/or institutions. (e.g., Center of Drug Evaluation, Advisory Committee, Key Opinion Lead, Medical Scientific Society);
  • Holding CRO/Partners accountable for the high-quality standards of their deliverables.

 
Qualification/Requirements:

Education:

  • Medical degree. Specialty in endocrinology is preferred.

Experience & knowledge:

  • Industry experience in clinical development and in medical affairs a strong plus;
  • Previous project/people management experience preferred;
  • Prefer participating or a key role in Phase III clinical study experience;
  • Fluent in verbal and oral English skills.



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