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[NMusers] Clinical Pharmacology Lead Opening at Pfizer

From: Krishnaswami, Sriram <Sriram.Krishnaswami_at_pfizer.com>
Date: Tue, 21 Apr 2015 21:31:08 +0000

https://globaljobs.pfizer.com/pages/jobs.aspx
Job ID: 1011589

All over the world, Pfizer colleagues are working together to positively im=
pact health for everyone, everywhere. Each position at Pfizer touches and c=
ontributes to the success of our business and our world. That's why, as one=
 of the global leaders in the biopharmaceutical industry, Pfizer is committ=
ed to seeking out inspired new talent who share our core values and mission=
 of making the world a healthier place.

Role Description
The Clinical Pharmacology Lead serves as the Clinical Pharmacology represen=
tative on multidisciplinary development teams and provides clinical pharmac=
ology expertise and leadership to a project. The position entails partnerin=
g with development colleagues to integrate prior knowledge in order to deve=
lop innovative clinical development strategies and study designs for Phase =
1-IV clinical trials by applying the principles of model based drug develop=
ment The position entails partnering with development colleagues to integra=
te prior knowledge in order to develop innovative clinical development stra=
tegies and study designs for Phase 1-IV clinical trials by applying the pri=
nciples of model based drug development in the area of inflammation & Immun=
ology.
Clinical Pharmacology Leads work closely with clinicians and statisticians =
to create clinical development plans that include assessments of a drug's e=
fficacy, safety, commercial viability and fulfillment of registration requi=
rements. The Clinical Pharmacology Lead has primary responsibility for the =
clinical pharmacology components of the development plan.

In order to achieve these aims, Clinical Pharmacology Leads are responsible=
 for the use of innovative analytical methods to integrate knowledge of pha=
rmacokinetics, biopharmaceutics, pharmacodynamics, patient characteristics =
and disease states to optimize doses, dosage regimens and study designs, an=
d to provide clinical pharmacology support and leadership in the preparatio=
n and defense of regulatory submissions.

Clinical Pharmacology Leads routinely interact with internal governance bod=
ies, regulatory agencies and external opinion leaders. They are expected an=
d encouraged to influence the external environment by advancing their disci=
pline through external presentations and publications.

Responsibilities
* Serves as the Clinical Pharmacology representative on Drug Development an=
d Clinical Sub-Teams from post proof-of concept (POC) through loss of exclu=
sivity and provides clinical pharmacology expertise and leadership to proje=
cts
* Responsible for use of innovative analytical methods to integrate knowled=
ge of pharmacokinetics, pharmacodynamics, patient characteristics and disea=
se states to determine probability of success, optimize doses, dosage regim=
ens and study designs throughout clinical drug development
* Plans and directs clinical pharmacology components of clinical programs (=
including clinical development plan) and studies (including synopsis prepar=
ation; clinical phase oversight, when appropriate; reporting)
* Works with multifunctional study team to design, deliver and report the a=
ssigned clinical pharmacology studies and has overall scientific accountabi=
lity for the designated studies
* Responsible (with Clinicians and Statisticians) for ensuring appropriate =
dose-finding strategies during clinical drug development that will ensure o=
ptimal 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).
* Responsible for appropriate summarization and interpretation of results o=
f pharmacokinetic/pharmacodynamic (PK-PD) analyses, including quantitative =
contextualization of competitor data with respect to their impact on develo=
pment and clinical use of drugs
* During the pre-POC stage of drug development, collaborates with Clinical =
Research to ensure that principles of model-based drug development have bee=
n applied to planning for POC
* Provides clinical pharmacology support and leadership in the preparation =
and defense of regulatory submissions

Qualifications
EDUCATION AND EXPERIENCE

The ideal candidates will have a doctorate degree with demonstrated experti=
se in clinical pharmacology and/or pharmacometrics and strong quantitative =
skills (e.g. experience in mechanistic modeling/systems pharmacology, quant=
itative translational scaling, literature meta-analyses, population modelin=
g, and clinical trial simulations) using NONMEM, R etc.

TECHNICAL SKILLS REQUIREMENTS

PK/PD modeling and simulation skills such as those listed above
Excellent verbal and written communication skills

PHYSICAL POSITION REQUIREMENTS
This is an "office"-based job that will require the ability to travel

EEO & Employment Eligibility
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 expressi=
on, national origin, disability or veteran status. Pfizer also complies wit=
h all applicable national, state and local laws governing nondiscrimination=
 in employment as well as work authorization and employment eligibility ver=
ification requirements of the Immigration and Nationality Act and IRCA. Pfi=
zer is an E-Verify employer.

Sunshine Act
Pfizer reports payments and other transfers of value to health care provide=
rs as required by federal and state transparency laws and implementing regu=
lations. These laws and regulations require Pfizer to provide government ag=
encies with information such as a health care provider's name, address and =
the type of payments or other value received, generally for public disclosu=
re. Subject to further legal review and statutory or regulatory clarificati=
on, which Pfizer intends to pursue, reimbursement of recruiting expenses fo=
r licensed physicians may constitute a reportable transfer of value under t=
he federal transparency law commonly known as the Sunshine Act. Therefore, =
if you are a licensed physician who incurs recruiting expenses as a result =
of interviewing with Pfizer that we pay or reimburse, your name, address an=
d the amount of payments made currently will be reported to the government.=
 If you have questions regarding this matter, please do not hesitate to con=
tact your Talent Acquisition representative.

Received on Tue Apr 21 2015 - 17:31:08 EDT

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