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Senior Director, Clinical Pharmacology Lead

Employer
Pfizer
Location
Collegeville, Pennsylvania
Salary
Competitive
Closing date
Jun 26, 2022

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Discipline
Life Sciences, Pharmacology
Position Type
Full Time
Job Type
President/CEO/Director/VP
Organization Type
All Industry, Pharma
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.

We have an exciting opening for a Clinical Pharmacology Lead with a PhD or PharmD with at least 12 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 Inflammation and Immunology therapy area. The successful candidate will have broad extensive knowledge of clinical pharmacology, drug development, regulatory requirements as well as 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
  • Provide clinical pharmacology leadership at the asset and/or portfolio level.
  • Identify opportunities where model-informed drug development (MIDD) approaches can advance the understanding of pharmacological activity, efficacy and safety for projects and across the portfolio.
  • Act as Clinical Pharmacology representative providing clinical pharmacology expertise to a multidisciplinary study team for a late-stage Internal Medicine program(s).
  • Leadership in implementing quantitative approaches to address questions arising during drug development (including dose selection, clinical trial design, special population dosing, benefit/risk assessment).
  • Work closely with Clinical, Statistics, Pharmacometrics, and Clinical Operations colleagues to design, conduct and report results of Clinical Pharmacology trials, including population PK, PK-PD modeling and simulation, meta-analysis, etc.
  • 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.
  • Influence environment outside of Pfizer through methods such as publications and presentations.
  • Provide input to the strategy around development of standards, new methodology, tools, software, hardware, and related business processes
  • Train, develop, and mentor other clinical pharmacology colleagues.
  • Accountable for non-compartmental analysis of PK data and accountable for ensuring appropriate PK-PD analysis

BASIC QUALIFICATIONS
  • PhD, Pharm.D. with 10 years or more 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.
  • Excellent written and verbal communication skills.

Candidates from alternative backgrounds (e.g. mathematics, engineering, system biology, medicine) will be considered if they can demonstrate relevant experience and expertise.

PREFERRED QUALIFICATIONS
  • Strong publication record in relevant discipline
  • Experience with regulatory submissions


In addition to professional challenge, we offer a culture that supports and encourages ideas, and recognizes individual contribution.

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.
Relocation support available

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

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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