職位描述
工作職責:
Position Purpose:Responsible for designing and implementing a Clinical Pharmacology plan that conforms to appropriate regulatory guidelines such that rational development and registration of drug candidates can be rapidly achieved in China.
Serves as the Clinical Pharmacology representative on drug development and clinical sub-teams and provides clinical pharmacology expertise and leadership to projects.
Plans and directs clinical pharmacology components of clinical programs (including clinical development plan) and studies (including design, clinical phase oversight, synopsis preparation and reporting).
Leads multifunctional study team to design, deliver and report the assigned clinical pharmacology studies and has overall scientific accountability for the designated studies.
Responsible (with Clinicians and Statisticians) for ensuring appropriate dose-finding strategies during clinical drug development that will ensure optimal doses and dosage regimens in patients.
Accountable for the development and implementation of a clinical modeling and simulation plan based on agreed upon best practices (i.e. model-based drug development) in collaboration with Pharmacometrics.
Responsible for use of quantitative methods to integrate knowledge of pharmacokinetics (PK), pharmacodynamics (PD), patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development.
Responsible for appropriate summarization and interpretation of results of PK-PD analyses with respect to their impact on development and clinical use of drugs.
In collaboration with global Business Unit, evaluates PK (and/or PD) and safety results among ethnic groups to contribute to the faster submission and authorization in China utilizing global study results.
Provides clinical pharmacology support and leadership in the preparation and defense of regulatory submissions.
Organizational Relationships:Solid line report within the line organization of Development China.
Collaborates closely with project team members, particularly with other triad colleagues from Clinical Development, Statistics and Pharmacometricians.
Provides matrix leadership to a wider Clinical Pharmacology team (e.g. from Global Clinical Pharmacology including US/EU Clinical Pharmacology Leads, Pharmacometrics, Clinical Assay Group), particularly for larger projects.
Other important partnerships can include Development Operations, Pharmacokinetics, Dynamics and Metabolism (PDM), Drug Safety R
任職資格:
Qualifications and Attributes:
?Educational: Pharm. D., Ph.D., or equivalent training or experience in pharmacokinetics, pharmacometrics, clinical pharmacology or related discipline.
?Considerable organizational awareness (inter-relationship of departments, business priorities, etc.)
Technical Competencies
?Clinical pharmacology: demonstrates cursory understanding of the following: 1) principles of PK, PK-PD and pharmacology relevant to drug candidates; 2) other relevant scientific disciplines, including drug metabolism, drug transport, formulation sciences, biopharmaceutics, pathophysiology and therapeutics; and 3) quantitative modeling and simulation principles
?Communication skills: Demonstrates ability to effectively present PK/PD data, clinical pharmacology development plans and strategies to various audiences in both verbal and written form (English and Mandarin); demonstrate ability to write PK/PD results, interpretations (including impact) and conclusions for clinical study reports and regulatory documents that are clear and concise.
?Regulatory knowledge: Understands and is able to apply appropriate China FDA, US FDA, EMA and ICH guidelines in the design of clinical development plans and studies with close supervision
