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Associate Director/Director Position in Clinical Pharmacology at Pfizer Oncology, La Jolla, CA

From: Wang, Diane <Diane.Wang>
Date: Fri, 6 Dec 2013 21:37:36 +0000

Please see a job posting below.

Pfizer is currently hiring an Associate Director/Director, Clinical Pharmacology, at the La
Jolla, CA facility.

Interested applicants must submit their resume online via
www.pfizercareers.com.

Apply directly to job 988463.

**Resumes CANNOT be accepted via email**

Diane

Diane D. Wang, Ph.D.
Senior Director
Clinical Pharmacology
Oncology Business Unit
Pfizer La Jolla
10555 Science Center Dr. (CB10/1719)
San Diego, CA 92121
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Org 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
•Responsible to deliver a drug interaction plan based on pharmacokinetic (e.g. metabolism, transporters) and pharmacodynamic properties of the candidate as well as the medical/commercial needs.
•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


•Ph.D., Pharm.D. or equivalent training in pharmacokinetics, pharmaceutical sciences or related disciplines.
•4+ 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 Skill 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 employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must be authorized to work for Pfizer in the U.S. at the time of the commencement of employment. Foreign national applicants who will need employer immigration sponsorship to obtain or continue work authorization must disclose that fact as part of the application process. Pfizer may consider in its sole discretion sponsoring a foreign national applicant for work authorization and/or permanent residence (green card) depending on its business needs.
















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Received on Fri Dec 06 2013 - 16:37:36 EST

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