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Associate Director - Clinical ...

Monster
 
 
 
 

Job Summary

Company
Pfizer
Location
Groton, CT
Industries
Other/Not Classified
Job Type
Full Time
Employee
Career Level
Experienced (Non-Manager)
Job Reference Code
4903_4699755

Associate Director - Clinical Pharmacology

About the Job

ROLE SUMMARY

We have an exciting opening for a Clinical Pharmacology Lead with a PhD or PharmD with at least 5 years of drug development experience. Pfizer is a leader in model-based drug development and you will be an integral member of the Pfizer Clinical Pharmacology team, supporting late stage programs in the Internal Medicine therapy area. The successful candidate will have strong quantitative pharmacology skills with hands-on experience in the implementation of common software tools (e.g., NONMEM, R) for PK and PK/PD analyses. Self-motivation, strong scientific reasoning and communication (both verbal and writing) skills, and the ability to function effectively in a team environment are highly desirable.

ROLE RESPONSIBILITIES

The candidate will be working as a CPL to support development projects in Internal Medicine, including designs of the clinical pharmacology or clinical studies, establishing PK/PD plans, performing PK/PD analysis, reporting results, writing Clin Pharm sections of the CSR, supporting the development of submission documents (briefing book, NDA, MAA, etc). The candidate will be responsible for designing/planning Clinical Pharmacology studies in collaboration with other team members.

  • Act as Clinical Pharmacology representative providing clinical pharmacology expertise to a multidisciplinary study team for a late-stage Internal Medicine program(s).
  • Participate in implementing model-informed drug development using quantitative approaches to address questions arising during drug development (including dose selection, clinical trial design, special population dosing, benefit/risk assessment).
  • Work closely with clinicians, statisticians, and clinical operations colleagues to design, conduct and report results of Clinical Pharmacology trials.
  • Accountable for non-compartmental analysis of PK data and accountable for ensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, meta-analysis, etc.
  • Able to interpret PK and PK/PD data and integrate this knowledge into the clinical trials and the overall clinical program.
  • Responsible for providing the clinical pharmacology components of protocols, clinical development plans and regulatory documents.
  • Influences environment outside of Pfizer through methods such as publications and presentations.

QUALIFICATIONS

  • PhD, Pharm.D. with 5-8 years of drug development experience in clinical pharmacology and/or clinical PK/PD and/or pharmacometrics
  • Strong quantitative skills and expertise (e.g. experience in population modeling, literature meta-analyses, and clinical trial simulations) with hands-on implementation of tools such as NONMEM, R, SAS, or WinBUGS for data analysis and handling
  • Effective verbal and written communication skills are essential for the role.

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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