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Director, Clinical Pharmacology


Cambridge, MA
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Job Details

Job Title Director, Clinical Pharmacology

JobID 1037749-1852

Location: Cambridge, MA

Description *About Pfizer*

A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

*Role Description*

Responsible for all aspects of clinical pharmacology relating to early clinical development of the programs under his/her purview within the assigned Research Units and for working with clinical colleagues to ensure innovative clinical strategy, model-based drug development, optimal use of all available information and optimal dose selection up to phase 2b. Additionally, the incumbent will be responsible for optimal design of phase 1 studies, considering translational and safety components.


Serves as the Clinical Pharmacology representative on development and clinical teams and provides clinical pharmacology expertise and leadership to a project * 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 appropriate design and implementation of a clinical modeling and simulation plan that conforms to appropriate regulatory guidelines* Responsible for appropriate summarizing, modeling and interpreting results of pharmacokinetic/pharmacodynamics analyses with respect to their impact on development and clinical use of drugs* Responsible for ensuring clinical plans reflect a strong emphasis on quantitative components via partnering with clinicians, statisticians, geneticists, precision medicine and Pharmacometrics* Supporting application of human confidence in rationale during target selection/validation and matching the target/patient to improve the probability of a positive proof-of-concept via application of appropriate (eg systems) approaches* During the pre-clinical stages of drug development works with Research to ensure that sufficient preclinical PK-PD knowledge exists to underwrite safe human administration.* Responsible for/inputs to design of phase 1 studies considering safety and translational aspects primarily to support onward drug development * Provides all Clinical Pharmacology input to regulatory documents and responses * Represents department on internal workstreams aimed at optimizing how we run our early clinical trials and/or interactions around clinical pharmacology across Pfizer* Stays abreast of literature, government guidelines, internal guidance on clinical trial conduct including Good Clinical Practice and internal SOPs, regulations for specific projects to which assigned, in order to be a team resource of clinical pharmacology knowledge in terms of both therapeutic area background and clinical trial design * Ability to produce and present quality scientific papers at external meetings and for publication.


*PhD in pharmacokinetics, pharmacometrics, mathematics, engineering or Pharm D or other suitable post-graduate qualification*At least 8 years' experience in clinical pharmacology and/or clinical PK/PD and/or pharmacometrics work primarily in the pharmaceutical industry*Strong quantitative skills in modeling and simulationsPHYSICAL/MENTAL REQUIREMENTS * Ability to perform mathematical calculations* Ability to perform complex data analysis* Ability to relate clinical pharmacology to the broader development paradigmNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Infrequent travel required.

*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.

*Director, Clinical Pharmacology*
*Cambridge, Massachusetts*

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