Job Opportunities

Clinical Pharmacology (Senior Manager or Manager)

Department: Clinical Pharmacology
Job Title: Clinical Pharmacology (Senior Manager or Manager)
Report to: Clinical Pharmacology, Senior Director
Location: China

MAIN REPONSIBILITIES:

  • Conducts clinical pharmacology studies in line with product development strategies, ensure working process following regulatory requirement and scientifically sensible.
  • Work with Leader for Clinical Pharmacology and/or Pharmacometrics Development Plan for Company compounds.
  • Performs and assists PKPD analysis for understanding of PKPD relationship for drug effect and dose selection to ensure development of safe & effective dosing regimens for various patient sub-populations & also ensure optimal drug development.
  • Participates in project meeting, and actively involved in data analysis, study preparation for the update and issue solving.
  • Interacts with Clinical Pharmacology Key Opinion Leaders and Healthy Authority reviewers; Ensures Company Clinical Pharmacology strategies adapts to science and regulatory advances.
  • Main author of clinical pharmacology/pharmacokinetic reports and regulatory submissions and be responsible for PopPK section for clinical protocols.
  • Works closely with Clinical Pharmacology CROs for outsourced studies.
  • Proactively identifies and resolves Clinical Pharmacology related issues as they arise.
  • Acts as QC SME in Clinical Pharmacology function.

QUALIFICATIONS:

  • Ph.D. or equivalent in Pharmacometrics, Clinical Pharmacokinetics, Clinical Pharmacology, or similar disciplines where quantitative pharmacology is emphasized.
  • At least 5 years relevant experience.
  • Rich experience in a pharmaceutical/biotech company, CRO, or academic medical center, or related experience
  • Extensive knowledge of Good Clinical Practice
  • Demonstrated leadership in understanding of the drug development and in cross functional working.
  • Advanced ability to problem-solve and conflict resolution.
  • Operational expertise in risk management and contingency planning
  • Outstanding oral and written communication skills and ability to interface effectively with all levels.
  • Excellent oral and written English; fluent in Chinese; able to independently use both English and Chinese to write documents and communicate with peers and experts.