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Clinical Pharmacology Lead positions at Pfizer, China

From: Xie, Rujia <Rujia.Xie>
Date: Wed, 9 Dec 2015 05:41:19 +0000

There are open positions at China Development, Pfizer, (Shanghai or Beijing=
) China

Clinical Pharmacology Lead (Director/Manager)


* Responsible for designing and implementing a Clinical Pharmacolog=
y plan that conforms to appropriate regulatory guidelines such that rationa=
l development and registration of drug candidates is rapidly achieved in Ch=

* Serves as the Clinical Pharmacology representative on drug develo=
pment and clinical sub-teams and provides clinical pharmacology expertise a=
nd leadership to projects.

* Plans and directs clinical pharmacology components of clinical pr=
ograms (including clinical development plan) and studies (including design,=
 synopsis preparation and reporting).

* Works with multifunctional study team to design, deliver and repo=
rt the assigned clinical pharmacology studies and has overall scientific ac=
countability for the designated studies.

* Responsible (with Clinicians and Statisticians) for ensuring appr=
opriate 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. mode=
l-based drug development) in collaboration with Pharmacometrics.

* Responsible for use of quantitative methods to integrate knowledg=
e of pharmacokinetics, pharmacodynamics, patient characteristics and diseas=
e states to optimize doses, dosage regimens and study designs throughout cl=
inical drug development.

* Responsible for appropriate summarization and interpretation of r=
esults 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 requ=
ired 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 clin=
ical pharmacology profile of allocated drugs for which studies are being co=
nducted 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 r=
esponsible, in conjunction with medical writer, for overall content and acc=
uracy of study report before forwarding for final sign-off. Assists with i=
nternal and external dissemination of results to Development Team, Investig=
ators etc.

* In cooperation with Global (ex China) Clinical Pharmacology and D=
evelopment Teams, evaluate and compare PK (and/or PD) and safety results am=
ong ethnicity to contribute to the faster submission and authorization util=
izing Global study results.

* Provides clinical pharmacology support and leadership in the prep=
aration and defense of regulatory submissions.

* May supervise, coach and develop less experienced Clinical Pharma=
cology Leads.

Qualifications and Attributes:

* Education: Pharm. D., Ph.D., or equivalent training or experienc=
e in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering =
or related discipline.

* Considerable organizational awareness (inter-relationship of busi=
ness 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 ca=
ndidates; 2) other relevant scientific disciplines, including drug metaboli=
sm, drug transport, formulation sciences, biopharmaceutics, pathophysiology=
 and therapeutics; and 3) quantitative modeling and simulation principles

* Communication Skills: Demonstrates ability to effectively presen=
t PK/PD data, Clinical Pharmacology Development Plans and strategies to var=
ious audiences in both verbal and written form (English and Mandarin); demo=
nstrate ability to write PK/PD results, interpretations (including impact) =
and conclusions for Clinical Study Reports and regulatory documents that ar=
e clear and concise.

* Regulatory Knowledge: Understands and is able to apply appropria=
te China FDA, US FDA, EMA and ICH guidelines in the design of clinical deve=
lopment plans and studies.

To apply please visit the careers pages on<
.com> and enter the following job opening number:

Director, Clinical Pharmacology Lead: Job ID 1023611
Manager, Clinical Pharmacology Lead: Job ID 1023612

Received on Wed Dec 09 2015 - 00:41:19 EST

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