SciPro is retained by a Top 5 pharma company to hire a Manager, Clinical Pharmacology Lead to join the Oncology Clinical Pharmacology team within the Early Clinical Development Clinical Pharmacology group, based in La Jolla/San Diego, CA. With some guidance from senior leads, the individual will be responsible for developing and implementing the Clinical Pharmacology Plan and Modeling-Informed Drug Development strategies 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.
Help develop clinical pharmacology plan for early oncology drug development programs, including both small and large molecules with some guidance from senior leads.
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 PK, PK/PD, 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.) or equivalent experience in Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, Engineering, Systems Biology or other related disciplines.
2-4 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 hands-on experience in computational tools (e.g. R, NONMEM)