There are open positions at China Development, Pfizer, (Shanghai or Beijing) China
Clinical Pharmacology Lead (Director/Manager) Responsibilities: * Responsible for designing and implementing a Clinical Pharmacology plan that conforms to appropriate regulatory guidelines such that rational development and registration of drug candidates is 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, synopsis preparation and reporting). * Works with 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, pharmacodynamics, 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 pharmacokinetic/ pharmacodynamic (PK-PD)analyses with respect to their impact on development and clinical use of drugs. * Plans, designs and oversees clinical pharmacology studies as required throughout post-POC drug development with operational assistance from Development Operations. Accountable and responsible for assigned synopsis and study report content. * With study team, tracks emerging clinical pharmacology profile of the drug, keeps line management informed of changes in the profile as they occur in the assigned studies. Must be fully knowledgeable about the clinical pharmacology profile of allocated drugs for which studies are being conducted or which are called for in the protocol (e.g. interacting drug). * Coordinates with medical writers (and other team members) in the data review, analysis and reporting of clinical pharmacology studies. Is responsible, in conjunction with medical writer, for overall content and accuracy of study report before forwarding for final sign-off. Assists with internal and external dissemination of results to Development Team, Investigators etc. * In cooperation with Global (ex China) Clinical Pharmacology and Development Teams, evaluate and compare PK (and/or PD) and safety results among ethnicity to contribute to the faster submission and authorization utilizing Global study results. * Provides clinical pharmacology support and leadership in the preparation and defense of regulatory submissions. * May supervise, coach and develop less experienced Clinical Pharmacology Leads. Qualifications and Attributes: * Education: Pharm. D., Ph.D., or equivalent training or experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering or related discipline. * Considerable organizational awareness (inter-relationship of business units, departments, business priorities, etc.) * Effective supervisory experience. Technical Competencies: * Clinical pharmacology: demonstrates thorough 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. To apply please visit the careers pages on www.pfizer.com<http://www.pfizer.com> and enter the following job opening number: Director, Clinical Pharmacology Lead: Job ID 1023611 Manager, Clinical Pharmacology Lead: Job ID 1023612
