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-San Diego, 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 prior industry experience in clinical pharmacology with expertise in PK/PD modeling.
• 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.
• 4+ years of industry or equivalent experience in clinical pharmacology and/or clinical PK/PD and/or pharmacometrics.
• Proficiency in mathematical modeling and programming as demonstrated by hand-on experience in computational tools (e.g. R, 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 experiencesupporting clinical pharmacology investigations for oncology clinical development programs is desirable.
• Relocation eligible
• Eligible for employee referral bonus