Clinical Pharmacology Lead
Location: La Jolla
Posted on: April 18, 2019
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
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.
With appropriate mentorship:
- Helps developing clinical pharmacology plan for early oncology
drug development programs, including both small and large
- 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
- 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
- Helps authoring clinical pharmacology components of clinical
documents including protocols, investigator brochures, clinical
development plans, and study reports; author scientific
- 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.
- 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,
- 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
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providers as required by federal and state transparency laws and
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to provide government agencies with information such as a health
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value received, generally for public disclosure. Subject to further
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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
Keywords: Pfizer, San Diego , Clinical Pharmacology Lead, Healthcare , La Jolla, California
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