Pharmacometrician (Manager)

Employer
Pfizer
Location
La Jolla, California
Posted
Jul 30, 2021
Ref
4811888
Required Education
Doctorate/PHD/MD
Position Type
Full time

JOB SUMMARY

  • Implements model informed drug development (MIDD) plans across projects and disease areas in order to optimize prospective studies, inform drug development strategy and project decision-making, in collaboration with partners.
  • Conducts and reports quantitative analyses which integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics, and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development.
  • Identifies opportunities where modeling and simulation can advance the understanding of pharmacological activity, efficacy and safety.
  • May help in providing support and/or development of quantitative methodology, pharmacometrics tools, software, hardware, and related business processes

JOB RESPONSIBILITIES

  • 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, quantitative knowledge management, decision analysis, and EQDD strategy in collaboration with partners.
  • Prepares formal presentations and written reports to Pfizer standards.
  • Provide Quantitative Clinical Pharmacology expertise on multidisciplinary development teams, working closely with clinical pharmacologists, clinicians and statisticians to create clinical development plans that include assessments of a drug's efficacy, safety, and commercial viability.
  • May contributes with project teams/partners to regulatory documents.
  • 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.

QUALIFICATIONS / SKILLS

Basic Qualifications:

  • Masters Degree with 4+ years of experience OR PhD, DSc, PharmD, DPhi, D.Eng, D.E.Sc, MD with 0 years of experience required.
  • Strong quantitative skills (e.g., pharmacometrics, pharmacokinetics, mechanistic modeling/systems pharmacology, literature meta-analyses, clinical trial simulations, statistics).
  • Experience using R software
  • Good communication skills (written, oral presentation)

Preferred Qualifications:

  • Other pharmacometric software experience (e.g. Nonmem, PsN, MATLAB)
  • Other statistical software experience (e.g. Stan)
  • Other programming experience (e.g. Python, C++)
  • We encourage applicants from different disciplines including clinical pharmacology, engineering, biostatistics, medicine, biology, etc. 

Candidates with significant experience are also sought. In addition to professional challenge, we offer a culture that supports and encourages ideas, and recognizes individual contribution.

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

Relocation support available

Eligible for Employee Referral Bonus

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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