Pharmacometrics Group Lead (Executive Director)--Oncology

ROLE SUMMARY

Supporting Pfizer Oncology, you will be a senior scientific and strategic leader and a member of the Pharmacometrics and Systems Pharmacology Leadership Team. In this key role, you will influence the discovery and development of drugs and expand the application of model-informed drug development (MIDD) approaches within oncology and across our portfolio.

You will lead a team of talented pharmacometricians to evaluate risk/benefit and facilitate drug development decisions by constructing, validating, and utilizing disease, placebo, exposure-response, and mechanistic PKPD models and other quantitative approaches. You will partner with key stakeholders and colleagues in Clinical Pharmacology, Quantitative Systems Pharmacology, Statistics, Translational Modeling and Simulation, and other Research and Development lines to accelerate breakthrough cancer medicines that bring new hope to patients everywhere.

ROLE RESPONSIBILITIES

• Provide scientific, technical, and strategic leadership of the pharmacometrics function within oncology, and other therapeutic areas as appropriate/needed.
• Provide oversight to the development of Model Informed Drug Development (MIDD) plans, involving planning and execution of quantitative analyses which may include population pharmacokinetics, pharmacokinetics (PK)/pharmacodynamics (PD), exposure response, disease progression modeling, model-based meta-analysis, and decision analysis. As needed, may develop individual MIDD plans and conduct the quantitative analyses.
• Manage a large team of Pharmacometricians and/or other Computational Scientists.
• Train, develop, and mentor pharmacometricians and other MIDD colleagues.
• Forecast pharmacometrics resourcing needs within the oncology therapeutic area.
• Provide guidance to our regulatory MIDD strategy
• 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.
• Influence and lead the external environment through scientific societies, publications, presentations, and collaborations.

BASIC QUALIFICATIONS

• PhD in Pharmaceutical Science, Math or related discipline or PharmD
• Strong quantitative experience (e.g., pharmacometrics, pharmacokinetics/pharmacodynamics, quantitative systems pharmacology, statistics)
• Minimum 10 years of pharmacometrics experience, including pharmacometics modeling in a drug development setting
• Experience managing a team of colleagues with advanced degrees (e.g., Ph.D., PharmD) including colleague development and performance management

• Proficient with pharmacometrics analysis and related software (e.g., NONMEM, R)
• Experience presenting pharmacometrics modeling analyses and data, and MIDD plans and strategies to various audiences in both verbal and written form;
• Experience writing pharmacometrics modeling results, interpretations (including impact) and conclusions for reports and regulatory documents that are clear and concise;
• Experience applying appropriate FDA and ICH guidelines in the design of MIDD plans and analyses, and preparation of pharmacometrics components of regulatory submissions and inquiries.

PREFERRED QUALIFICATIONS

• Pharmacometrics experience applied to oncology drug development
• Experience supporting pharmacometrics analyses for large and small molecules, including anti-body drug conjugates, bsAB, tsAb, and novel modalities.
• Strong track record of publications

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

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Occasional travel (several times/year), as needed.

Ability to regularly attend meetings during business hours on US Pacific time.

#LI-PFE

Relocation assistance may be available based on business needs and/or eligibility.

Sunshine Act

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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. This position requires permanent work authorization in the United States.