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Pharmacometrician (Manager level)

Employer
Pfizer
Location
La Jolla, California
Start date
Sep 22, 2022

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Job Details

JOB SUMMARY

  • With guidance, contribute to the development of the model informed drug development (MIDD) plans for an assigned project in order to optimize prospective studies, inform drug development strategy and project decision-making, in collaboration with partners.
  • Conduct and report quantitative analyses which integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics, and disease states to optimize doses, dosage regimens and study designs throughout all phases (first-in-human through post-approval) of clinical drug development.
  • With guidance, identify opportunities where MIDD approaches can advance the understanding of pharmacological activity, efficacy and safety
  • Provide support in the development and application of state-of-the-art quantitative methodologies, pharmacometrics tools, software, hardware, and/or related business processes

ROLE RESPONSIBILITIES

  • With guidance, 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 efficacy, safety, and commercial viability.
  • Responsible for the execution of relevant quantitative analyses which may include population pharmacokinetics,pharmacokinetics/pharmacodynamics, exposure response, disease progression modeling, model-based meta-analysis, quantitative knowledge management, and decision analysis for multiple analyses supporting a program.
  • Prepare formal presentations and written reports to Pfizer standards.
  • Contribute to regulatory documents (summary documents, briefing books, regulatory responses)
  • Stays abreast of literature, government guidelines, and internal guidance as relates to pharmacometrics and MIDD, including internal SOPs and regulations in order to be a team resource of pharmacometric knowledge and applications
  • 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.

BASIC QUALIFICATIONS

  • PhD in Pharmacometrics, Clinical Pharmacology, Pharmacokinetics, Engineering, Pharmaceutical Sciences, or PharmD
  • Strong quantitative modeling skills (e.g., pharmacometrics, pharmacokinetics, mechanistic modeling/systems pharmacology, statistics).
  • Experience with R software
  • Strong communication skills--written, oral and presentation

PREFERRED QUALIFICATIONS

  • Industry experience in Pharmacometrics, Clinical PK/PD and/or Clinical Pharmacology
  • Experience with Nonmem, PsN, MATLAB or other pharmaceutical software
  • Experience with other statistical software (e.g., Stan)
  • Programming experience (e.g., Python, C++)

ORGANIZATIONAL RELATIONSHIPS

  • Reports to Pharmacometrics Group Leader within the line organization of Pharmacometrics, GPD-Clinical Pharmacology
  • Matrixed relationships particularly with Clinical Pharmacology Leads, Clinicians, Statisticians, and colleagues from Programming groups and other groups as required


PHYSICAL/MENTAL REQUIREMENTS

Sitting, ability to perform complex data analyses


Work Location Assignment:Flexible

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

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

Company

Join world-class scientists and leaders who are dedicated to bringing therapies that will significantly improve patients' lives.

As one of the world's premier innovative biopharmaceutical companies, we're driven to discover the cure --driven to significantly improve the lives of everyone...everywhere. If you're similarly driven, you'll find there's no better place to begin --and continue --your career than at Pfizer.

Science is the foundation of our company.  This is why it's no surprise that the most driven scientists in the world choose to carry out their life's passion at Pfizer.  We arm them with the resources, technology, and facilities they need to solve some of the world’s most complex health challenges. This combination empowers our scientists with expertise in vaccines, small-molecule medicines, biotherapeutics amongst many others, to collaborate on breakthrough science, including the world's first mRNA-Based Covid19 vaccine.  Our colleagues advance science and technologies into the therapies that matter most.

Join us and you'll partner with colleagues of diverse backgrounds and abilities who contribute to all aspects of what we do. Great things happen when people come together with one shared goal. If you're driven to discover the cure- ensure it has the latest technology to make it a reality or help improve the lives of others- join those who are similarly driven at Pfizer. The future of medicine is happening here.

Visit www.pfizer.com and connect with us.

 

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Find Us
Website
Phone
(212) 733-2323
Location
235 East 42nd Street
New York, NY 10017
United States
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