Clinical Pharmacology (Senior Manager or Manager)
Department: Clinical Pharmacology
Job Title: Clinical Pharmacology (Senior Manager or Manager)
Report to: Clinical Pharmacology, Senior Director
- 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.
- 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.