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.
- Develop clinical pharmacology plan for early oncology drug development programs, including both small and large molecules.
- 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 developed from preclinical data to ensure adequate confidence in prediction of human PK and efficacious dose projections.
- Provide 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.
- Author 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.
- Advanced degree (Ph.D., Pharm.D., MD) or equivalent experience in Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, Engineering, Systems Biology or other related disciplines.
- 3-5 years of industry or equivalent experience in clinical pharmacology and/or clinical PK/PD and/or pharmacometrics (quantitative systems pharmacology 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.
- Prior experience in oncology, immunology or cancer biology in a drug development setting is desirable.
- Relocation eligible
- Eligible for employee referral bonus