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Clinical Pharmacology Lead, Associate Director

at Pfizer, Inc in Bentonville, Arkansas, United States

Job Description

ROLE SUMMARY

 

Serves as the Clinical Pharmacology representative for Phase 1 to 4 clinical studies supporting global development of Anti-Infectives.

 

Provides Clinical Pharmacology support for established product defense and maintenance activities for addressing regulatory queries and labeling updates.

 

Embraces Model Based Drug Development (MBDD) to facilitate development programs through use of Modeling and Simulation, integrating knowledge of pharmacokinetics, pharmacodynamics, and patient characteristics for adult and pediatric development programs, new indications, and product defense.

 

ROLE RESPONSIBILITIES

 

Provides clinical pharmacology representation on multi-disciplinary study teams for Anti-Infectives, Hospital products, and post-approval commitments.

 

Provides clinical pharmacology contributions at a study level (including protocols, analysis plans, clinical conduct, and study reports) and to global regulatory submission documents (IB, IND, pediatric plans, NDA, MAA).

 

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.

 

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.

 

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 established product maintenance.

 

QUALIFICATIONS

 

PhD or PharmD, Fellowship training preferred

 

At least 5 years of drug development experience (or equivalent) with at least 3 years in clinical pharmacology

 

In-depth knowledge of pharmacokinetics and related analysis software programs

 

Knowledge of regulatory guidance documents/standards and experience with regulatory agency interactions

 

Excellent written and oral communication skills

 

Organizational awareness (inter-relationship of departments, business priorities, etc.)

 

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

 

PHYSICAL/MENTAL REQUIREMENTS

Requires excellent analytical skills

 

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

 

Ability to travel locally and globally

 

Other Job Details

Eligible for Employee Referral Bonus

 

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.

 

Medical

 

#LI-PFE

 

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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Job Posting: 3096643

Posted On: Oct 18, 2021

Updated On: Nov 17, 2021