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Job Description Job Title : Associate Director, Clinical Pharmacology Lead - Oncology Job Id : 1007842 Target Openings : 1 Locations : United States-California-La Jolla Organizational Marketing Statement All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place. Role Description * 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 the U.S., EU, Asia and throughout the world * Responsible for NDA submission preparation and addressing Agency's queries * Responsible for designing and conducting clinical pharmacology studies such as drug-drug interaction, special population and bioequivalence studies * Responsible for designing dose-finding strategies during clinical drug development that will ensure optimal doses and dosage regimens in patients * Responsible for summarizing and interpreting results of clinical pharmacology studies, and pharmacokinetic/pharmacodynamic analyses with respect to their impact on development and clinical use of drugs * Responsible for using innovative analytical methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosing regimens and study designs throughout clinical drug development * Responsible for evaluating and applying new techniques in PK/PD data analysis that improve information quality and utility, and enhance productivity Responsibilities * Designs study protocols, analyzes PK/PD data and interprets results to meet the objectives of the Clinical Pharmacology Plan * Provides expertise to the Asset Team and the Clinical Sub-Team to optimize dose, dosing regimen, study designs and strategy based on exposure-response information * Plans and directs clinical pharmacology components of clinical programs and studies * Leads multifunctional study team to design, deliver and report the assigned clinical pharmacology studies and has overall scientific accountability for the designated studies. Conducts regulatory level non-compartmental analysis on data and takes scientific lead on clinical study report contribution * Accountable for appropriate design and implementation of a clinical modeling and simulation plan that conforms to appropriate regulatory guidelines * Summarizes results of PK/PD analyses in Clinical Study Reports (CSR) and publishes in peer reviewed journals * Presents study results both internally and externally * Contributes to summary documents for regulatory submissions * Contributes to regulatory strategy and is prepared to provide regulatory defense of the proposed label. Qualifications Education & Experience: * Ph.D., Pharm.D. or equivalent training in pharmacokinetics, pharmaceutical sciences or related disciplines. * 5+ years of postgraduate experience in Clinical Pharmacology, pharmacokinetic and/or pharmacodynamic research in industrial setting. * Clinical drug development, oncology drug development, and proven record of leadership are preferred Technical Skills Requirements: PK/PD: demonstrates thorough understanding of the following: 1) principles of PK, PK/PD; 2) data analysis using non-compartmental and model-based PK and PK/PD methods; 3) other relevant scientific disciplines, including drug metabolism, drug transport, formulation sciences, biopharmaceutics, pathophysiology and therapeutics especially oncology. 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; demonstrates ability to write PK/PD results, interpretations (including impact) and conclusions for Clinical Study Reports and regulatory documents that are clear and concise Scientific Excellence: demonstrates understanding of the complexities and recent developments in Clinical Pharmacology and the implications for drug development Regulatory Knowledge: understands and is able to apply appropriate FDA, EMA and ICH guidelines in the design of clinical development plans and studies. Equal Employment Opportunity Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer Diane D. Wang, Ph.D. Senior Director Clinical Pharmacology Pfizer Oncology 10555 Science Center Dr. (CB10/1719) San Diego, CA 92121 Office Phone: (858) 622-8021 Cell Phone: (858) 761-3667
