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Manager, Clinical Pharmacology

  • Location: La Jolla, CA

Posted about 1 month ago

  • Expiry Date: 27 November 2021

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.

Responsibilities:

  • 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.

Qualifications:

  • 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)