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Director, Clinical Pharmacology Lead

Pfizer


Location:
Groton, CT
Date:
04/06/2018
2018-04-062018-05-07
Pfizer
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Job Details

**ROLE SUMMARY**







+ Serves as the Clinical Pharmacology representative and provides expertise on designated clinical programs and studies for various therapeutic areas and portfolio segment teams (e.g. biosimilar, sterile injectable, or anti-infectives) for established products.



+ Provides Clinical Pharmacology support for product defense and maintenance activities for addressing regulatory queries and labeling needs.



+ Implements the use of Modeling and Simulation to integrate knowledge of pharmacokinetics, pharmacodynamics, and patient characteristics for pediatric development, new indications, and product defense.







**ROLE RESPONSIBILITIES**







+ Provides clinical pharmacology leadership on multi-disciplinary study teams for sterile injectables/Biosimilar/Anti-Infectives programs, post-approval commitments, and global bioequivalence studies.



+ Provides clinical pharmacology components at a project level (including clinical development plan) and at study level (including protocol preparation, clinical conduct, and reporting).



+ Responsible for interfacing with partner lines (e.g. clinical assay group, statistics, pharmacometrics) to ensure appropriate support for assigned programs and studies



+ Accountable for ensuring appropriate design and implementation of a clinical modeling and simulation plan and interpreting results.



+ Provides clinical pharmacology support and leadership in various regulatory interactions.



+ Assures that the clinical pharmacology strategy serves the overall objectives of the clinical program and is designed and executed to the highest scientific standards and delivers the data required to fulfill regulatory requirements.



+ Responsible for implementing clinical pharmacology best practices.



+ Represent clinical pharmacology to senior levels of the organization.



+ Influences environment outside of Pfizer through methods such as publication and presentations.



+ Responsible for addressing, writing and reviewing regulatory queries and labeling requests to support maintenance.







**QUALIFICATIONS**







+ PhD or Pharm D



+ At least 10 years of drug development experience with at least 5 years in clinical pharmacology



+ Demonstrated success in managing clinical pharmacology activities and Enhanced Quantitative Drug Development (Modeling and Simulations)



+ Experience in interactions with regulatory agencies globally



+ Considerable organizational awareness (inter-relationship of departments, business priorities, etc.)



+ Requires excellent analytical skills



+ Ability to travel locally and globally







**Other Information**







+ Eligible for employee referral bonus







**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.







**Sunshine Act**



Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government 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.







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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