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Clinical Pharmacology Lead

Company: Pfizer
Location: La Jolla
Posted on: April 18, 2019

Job Description:

ROLE SUMMARY

Clinical Pharmacology Leads at Pfizer are key members of multidisciplinary drug development project teams who provide subject matter expertise in quantitative pharmacology and are uniquely positioned to work at a technical level while having the opportunity to influence drug development strategy within the organization. Working closely with colleagues across research and development Clinical Pharmacology Leads apply their technical expertise to analyze, develop, validate and implement quantitative models to inform key drug development decisions. They are also responsible for design, conduct, oversight and reporting of clinical pharmacology components of clinical programs and studies.

We are seeking to hire a Clinical Pharmacology Lead to join the Clinical Pharmacology team within the Early Oncology Development and Clinical Research group, based in La Jolla, CA. The individual will be responsible for developing and delivering the clinical pharmacology and modeling & simulation strategy for early oncology programs using state-of-the-art quantitative methodologies to integrate knowledge of cancer biology, pharmacology, pharmacokinetics (PK), pharmacodynamics (PD) and disease-progression. The ideal candidate will have hands-on experience in the use of mechanistic mathematical models with a track record of success demonstrated through publication in high-quality peer-reviewed journals.

ROLE RESPONSIBILITIES

With appropriate mentorship:


  • Helps developing clinical pharmacology plan for early oncology drug development programs, including both small and large molecules.
  • May act as clinical pharmacology subject matter expert on multidisciplinary teams working closely with clinicians, biostatisticians, translational oncology and clinical operations colleagues to design, conduct and report clinical trials from first-in-patient to proof-of-concept; responsible for clinical pharmacology components including pharmacokinetics, pharmacodynamics, food effect (oral compound), drug-drug interaction, QTc, and immunogenicity (biologics).
  • Collaborate with preclinical scientists and analyze translational models to ensure quantitative mechanistic understanding and preclinical PK-PD knowledge exist to underwrite human administration.
  • Contribute to scientific justification for optimal human starting dose and dose escalation schemes for oncology first-in-patient protocols based on all available preclinical information including toxicology, efficacy models, physicochemical and biochemical characterization.
  • Work closely with clinical assay specialists to ensure that appropriate and validated bioanalytical assays are available on time for measuring drug concentration and anti-drug antibodies (for biologics) for clinical studies.
  • Conduct PK data analysis and develop computational models from PK/PD, safety and efficacy data collected in early stage clinical trials to support key program decision-making.
  • Present clinical pharmacology results to internal and external stakeholders.
  • Helps authoring clinical pharmacology components of clinical documents including protocols, investigator brochures, clinical development plans, and study reports; author scientific publications.
  • Align with global clinical pharmacology groups at Pfizer to maintain consistency with best practices and ensure the state-of-the-art quantitative approaches are being applied to inform key drug development decisions.

    BASIC QUALIFICATIONS

    • Advanced degree (Ph.D., Pharm.D., MD) or equivalent experience in Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, Engineering, Systems Biology or other related disciplines.
    • 0-3 years of industry or equivalent experience in clinical pharmacology and/or clinical PK/PD and/or pharmacometrics (quantitative systems pharmacology-QSP is a plus).
    • Proficiency in mathematical modeling and programming as demonstrated by hand-on experience in computational tools (e.g. R, MATLAB, NONMEM)
    • Demonstrated ability to work in a highly collaborative, multi-disciplinary team setting.
    • Excellent verbal and written communication skills.
    • Self-directed and highly-motivated researcher, with willingness to learning new tools and approaches.

      OTHER JOB DETAILS

      • Eligible for Employee Referral Bonus
      • Eligible for Relocation Package

        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.N (Other) (United States of America)Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Keywords: Pfizer, San Diego , Clinical Pharmacology Lead, Healthcare , La Jolla, California

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