Pharmacometrics Group Lead

Profile

ROLE SUMMARY

• Provide pharmacometric leadership and manage a group of Pharmacometricians supporting a therapeutic area
• Develop and/or review model informed drug development (MIDD) plans in order to optimize prospective studies, inform drug development strategy and project decision-making, in collaboration with partners.
• Work closely with Clinical Pharmacology TA leader, Statistician, and Clinician to align MIDD strategy for therapeutic area early and late development
• Provide oversight to the planning, conduct, and reporting of quantitative analyses to optimize doses, dosage regimens and study designs throughout clinical drug development.
• Identify opportunities where MIDD approaches can advance the understanding of pharmacological activity, efficacy and safety for projects and across the therapeutic area.
• As part of pharmacometrics leadership team, provide input to the strategy around development of standards, new methodology, tools, software, hardware, and related business processes

ROLE RESPONSIBILITIES

• Manage a group of 4-8 pharmacometricians supporting a therapeutic area
• Provide oversight to the development of the MIDD plan, planning and execution of relevant quantitative analyses which may include population pharmacokinetics, pharmacokinetics/pharmacodynamics, exposure response, disease progression modeling, model-based meta analysis, and decision analysis.  As needed, may develop MIDD plan and conduct the quantitative analyses
• Provide guidance to regulatory strategy for pharmacometrics
• Contribute to the development or improvement of our tools, processes and methodology, including involvement in internal cross-functional workgroups or initiatives, external alliances or committees, consortia and academic relationships.
• Train, develop, and mentor Pharmacometricians or other clinical pharmacology colleagues.

BASIC QUALIFICATIONS

• Qualifications include PhD or equivalent degree with strong quantitative skills (e.g., pharmacometrics, pharmacokinetics, mechanistic modeling/systems pharmacology, statistics) and 10 years’ or more of experience in a quantitative field OR Masters Degree with 13+ years of experience.
• Expertise in analysis and programming software (e.g., Nonmem, R).
• Demonstrated experience in pharmacometric analyses
• Experience in drug development, and good understanding of Pharmacokinetics, Pharmacodynamics and Statistical Principles
• Good communication skills (written, oral).

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
• Management experience

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.
 

  
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

PHYSICAL/MENTAL REQUIREMENTS

Sitting, ability to perform complex data analyses

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.

Medical

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