The clinical pharmacology group at Pfizer is recruiting quantitative clinical
pharmacologists from entry level (Manager) to Senior Director in the post-
proof-of-concept (POC) space in inflammation, immunology and rare diseases
areas. Positions can be based in Collegeville (PA), New York (NY) or Groton
(CT). If interested, please contact
[email protected]<mailto:[email protected]> and
[email protected]<mailto:[email protected]>.
Role Description
The Clinical Pharmacology Lead serves as the Clinical Pharmacology
representative on multidisciplinary development teams and provides clinical
pharmacology expertise and leadership to a project. The position entails
partnering with development colleagues to integrate prior knowledge in order to
develop innovative clinical development strategies and study designs for Phase
1-IV clinical trials by applying the principles of model based drug development
The position entails partnering with development colleagues to integrate prior
knowledge in order to develop innovative clinical development strategies and
study designs for Phase 1-IV clinical trials by applying the principles of
model based drug development in the areas of inflammation & Immunology and rare
diseases. Clinical Pharmacology Leads work closely with clinicians and
statisticians to create clinical development plans that include assessments of
a drug's efficacy, safety, commercial viability and fulfillment of registration
requirements. 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
pharmacokinetics, biopharmaceutics, pharmacodynamics, patient characteristics
and disease states to optimize doses, dosage regimens and study designs, and to
provide clinical pharmacology support and leadership in the preparation and
defense of regulatory submissions.
Clinical Pharmacology Leads routinely interact with internal governance bodies,
regulatory agencies and external opinion leaders. They are expected and
encouraged to influence the external environment by advancing their discipline
through external presentations and publications.
Responsibilities
* Serves as the Clinical Pharmacology representative on Drug Development and
Clinical Sub-Teams from post proof-of concept (POC) through loss of exclusivity
and provides clinical pharmacology expertise and leadership to projects
* Responsible for use of innovative analytical methods to integrate knowledge
of pharmacokinetics, pharmacodynamics, patient characteristics and disease
states to determine probability of success, optimize doses, dosage regimens and
study designs throughout clinical drug development
* Plans and directs clinical pharmacology components of clinical programs
(including clinical development plan) and studies (including synopsis
preparation; clinical phase oversight, when appropriate; reporting)
* Works with multifunctional study team to design, deliver and report the
assigned clinical pharmacology studies and has overall scientific
accountability for the designated studies
* Responsible (with Clinicians and Statisticians) for ensuring appropriate
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. model-based drug
development).
* Responsible for appropriate summarization and interpretation of results of
pharmacokinetic/pharmacodynamic (PK-PD) analyses, including quantitative
contextualization of competitor data with respect to their impact on
development 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 been
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 expertise
in clinical pharmacology and/or pharmacometrics and strong quantitative skills
(e.g. experience in mechanistic modeling/systems pharmacology, quantitative
translational scaling, literature meta-analyses, population modeling, and
clinical trial simulations) using NONMEM, R etc. We are recruiting from entry
level (manager) to senior director level.
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
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.
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as required by federal and state transparency laws and implementing
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agencies with information such as a health care provider's name, address and
the type of payments or other value received, generally for public disclosure.
Subject to further legal review and statutory or regulatory clarification,
which Pfizer intends to pursue, reimbursement of recruiting expenses for
licensed physicians may constitute a reportable transfer of value under the
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 and the
amount of payments made currently will be reported to the government. If you
have questions regarding this matter, please do not hesitate to contact your
Talent Acquisition representative.