Principal Scientist, Clinical Pharmacologist/Modeling and Simulation
2 days ago
🏢 In-office - San Francisco
Description
• Perform pharmacokinetic data analysis, including non-compartmental and compartmental analyses, to derive relevant pharmacokinetic parameters. Analyses to be performed initially on data from nonclinical studies and subsequently from first-in-human clinical trials. Present results to interdisciplinary teams, contributing to project decisions and fostering a collaborative and transparent environment. • Drive the application of quantitative pharmacokinetic-pharmacodynamic (PK-PD) modeling to guide LYTAC dose selection, dose regimen optimization, and exposure-response relationships in non-clinical studies to aid in the selection of starting doses and dose regimen for first-in-human clinical trials. Iterative modification of PK-PD models as human data emerges. • Author regulatory submissions and serve as a pharmacokinetics/clinical pharmacology subject matter expert during interactions with regulatory agencies. • Collaborate closely with research and development teams to define project objectives and design innovative and scientifically rigorous pharmacokinetic studies that address the overall project goals. • Represent the clinical pharmacology function and provide subject matter expertise on cross-functional clinical study teams and at study dose level review meetings. • Contribute to the development of bioanalytical assays to quantify LYTAC concentrations and metabolites in various biological matrices.
Requirements
• PhD in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, or related field with at least 7-8 years of pharmacokinetics or PK/PD modeling experience within a pharmaceutical, biotechnology, or research setting. • Proven track record of designing, executing, and analyzing pharmacokinetic studies, integrating pharmacology and pharmacokinetics data to generate quantitative models, and experience developing analytical assays. Candidate with prior clinical pharmacology experience is preferred. • Strong proficiency in pharmacokinetic software (e.g., WinNonlin, NONMEM) and relevant modeling tools. • Ability to adhere to tight timelines across multiple research projects and adapt to changing priorities. • Highly motivated and organized team player with excellent written and oral communication skills and the ability to contribute to multiple projects simultaneously. • Creative problem solver with the desire and technical skills required to develop the novel approaches needed to characterize the pharmacokinetic profile for a new class of therapeutic proteins. • Prior experience authoring sections of INDs, clinical protocols, Investigator Brochures, and Clinical Study Reports pertaining to Clinical Pharmacology or nonclinical pharmacokinetic studies or data.
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