Pfizer

Pharmacometrician / Director

Employer
Pfizer
Location
La Jolla, California
Salary
Competitive
Posted
November 18 2020
Ref
4794782
Position Type
Full Time
Organization Type
Pharma
ROLE SUMMARY
  • Provide pharmacometric expertise and leadership to projects in support of the oncology portfolio.
  • Develop model informed drug development (MIDD) plans in support of projects and more broadly across disease areas in oncology in order to optimize prospective studies, inform drug development strategy and project decision-making, in collaboration with partners.
  • Plan, conduct and report 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.
  • Act as Subject Matter Expert (SME), including proactive support and development of quantitative strategy, methodology, software, hardware, and related business processes, in addition to training for colleagues in the global clinical pharmacology organization.


ROLE RESPONSIBILITIES
  • Provide MIDD expertise on multidisciplinary development teams, working closely with clinical pharmacologists, clinicians, and statisticians to create MIDD plans that include assessments of a drug's activity, efficacy, safety, and commercial viability in support of the oncology portfolio.
  • Responsible for the 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 supporting a program.
  • Prepare formal presentations and written reports to Pfizer standards.
  • Contribute to regulatory documents (summary documents, briefing books, regulatory responses).
  • Stay abreast of literature, government guidelines, and internal guidance as relates to pharmacometrics and MIDD.
  • Contribute or lead 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 less experienced Pharmacometricians or other clinical pharmacology colleagues.


BASIC QUALIFICATIONS
  • Qualifications include PhD or equivalent degree with 9+ years' or more of strong experience in a quantitative field (e.g., pharmacometrics, pharmacokinetics, mechanistic modeling/systems pharmacology, statistics) (or MS degree with 12+ years of experience).
  • Expertise in analysis and programming software (e.g., Nonmem, R).
  • Demonstrated experience in pharmacometric analyses.
  • Experience in drug development.
  • 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.
  • Sitting, ability to perform complex data analyses.
  • May include 5-10% travel (TBD based on COVID-19).
  • 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.


PREFERRED QUALIFICATIONS
  • Strong publication record in relevant discipline
  • Experience with regulatory submissions including oncology
  • Good understanding of Pharmacokinetics, Pharmacodynamics and Statistical Principles with experience in oncology applications.


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

Other Job Details:
  • Eligible for Relocation Package: YES
  • Eligible for Employee Referral Bonus: YES
  • Additional Posting Locations: La Jolla, CA, Boulder, CO, or US Remote


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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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