[NMusers] Associate Director, Clinical Pharmacology Oncology position open at Pfizer La Jolla site

From: Wang, Diane <Diane.Wang_at_pfizer.com>
Date: Tue, 10 Feb 2015 05:42:20 +0000

Please respond with CV and also apply at www.pfizer.com/careers<http://www.=
pfizer.com/careers>.

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 im=
pact health for
everyone, everywhere. Each position at Pfizer touches and contributes to th=
e success of our
business and our world. That's why, as one of the global leaders in the bio=
pharmaceutical
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 t=
hat conforms to
appropriate regulatory guidelines such that rational development and regist=
ration of drug
candidates is rapidly achieved in the U.S., EU, Asia and throughout the wor=
ld
* Responsible for NDA submission preparation and addressing Agency's querie=
s
* Responsible for designing and conducting clinical pharmacology studies su=
ch as drug-drug
interaction, special population and bioequivalence studies
* Responsible for designing dose-finding strategies during clinical drug de=
velopment that will
ensure optimal doses and dosage regimens in patients
* Responsible for summarizing and interpreting results of clinical pharmaco=
logy studies, and
pharmacokinetic/pharmacodynamic analyses with respect to their impact on de=
velopment and
clinical use of drugs
* Responsible for using innovative analytical methods to integrate knowledg=
e of
pharmacokinetics, pharmacodynamics, patient characteristics and disease sta=
tes to optimize
doses, dosing regimens and study designs throughout clinical drug developme=
nt
* Responsible for evaluating and applying new techniques in PK/PD data anal=
ysis that improve
information quality and utility, and enhance productivity
Responsibilities
* Designs study protocols, analyzes PK/PD data and interprets results to me=
et the objectives of
the Clinical Pharmacology Plan
* Provides expertise to the Asset Team and the Clinical Sub-Team to optimiz=
e dose, dosing
regimen, study designs and strategy based on exposure-response information
* Plans and directs clinical pharmacology components of clinical programs a=
nd studies
* Leads multifunctional study team to design, deliver and report the assign=
ed clinical
pharmacology studies and has overall scientific accountability for the desi=
gnated studies.
Conducts regulatory level non-compartmental analysis on data and takes scie=
ntific lead on
clinical study report contribution
* Accountable for appropriate design and implementation of a clinical model=
ing 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, pharmaceutica=
l sciences or related
disciplines.
* 5+ years of postgraduate experience in Clinical Pharmacology, pharmacokin=
etic and/or
pharmacodynamic research in industrial setting.
* Clinical drug development, oncology drug development, and proven record o=
f 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 dat=
a, Clinical
Pharmacology Development Plans and strategies to various audiences in both =
verbal and written
form; demonstrates ability to write PK/PD results, interpretations (includi=
ng impact) and
conclusions for Clinical Study Reports and regulatory documents that are cl=
ear and concise
Scientific Excellence: demonstrates understanding of the complexities and r=
ecent 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 emp=
loyment 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 vetera=
n status. Pfizer also
complies with all applicable national, state and local laws governing nondi=
scrimination in
employment as well as work authorization and employment eligibility verific=
ation requirements
of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify empl=
oyer



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


Received on Tue Feb 10 2015 - 00:42:20 EST

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