Associate Director, Clinical Pharmacology

Nurix•Brisbane, CA

1d•Onsite

About The Position

Associate Director, Clinical Pharmacology Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix’s extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin proteasome system to selectively decrease or increase cellular protein levels. Nurix’s wholly owned pipeline comprises targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene-B, an E3 ligase that regulates T cell activation. Position The Associate Director in the Clinical Pharmacology group will contribute to pharmacometric efforts across early and late-stage programs. As an early member of the Clinical Pharmacology group, you will have an opportunity to influence the direction of the clinical pharmacology group at Nurix. The successful applicant shall be proficient in developing and executing PK/PD modeling and simulation activities, such as but not limited to population PK/PD modeling, physiologically-based PK (PBPK) modeling and quantitative systems pharmacology (QSP) modeling. This includes data analysis and interpretation and presentation of findings to optimize doses, dosage regimens and study designs. The candidate will also author and review clinical pharmacology documents for submission and/or response to regulatory agencies. The candidate will be influential across multiple functions including individual contributors, development program teams, and the executive team.

Requirements

PharmD or PhD or MS in a field related to Pharmacometrics with 8+ years of industry or similar experience in Pharmacometrics, Clinical Pharmacology or Quantitative Systems Pharmacology
Extensive hands-on experience in using modeling and simulation techniques in pharmaceutical development, such as population PK/PD modeling, PBPK modeling or QSP modeling
Exceptional oral and written communication skills and excellent problem-solving skills
Previous experience in authoring and reviewing clinical pharmacology documents for submission and/or response to regulatory agencies
Demonstrated past performance of functioning efficiently in a dynamic, cooperative, team-oriented environment showcasing emotional intelligence (respect and empathy)
High proficiency in using common software and data analysis packages (e.g., R, WinNonlin, Simcyp, GastroPlus, Monolix, NONMEM)

Responsibilities

Utilize quantitative approaches to impact model-informed drug discovery and development in areas such as human dose projections, dose regimen identification and optimization
Lead and conduct pharmacometric workstreams such as but not limited to noncompartmental analyses, exposure-response analyses, population PK/PD modeling, PBPK modeling and QSP modeling, and running model-based simulations
Conduct exploratory modeling activities to support decision-making and clinical strategy
Collaborate across functions within the company and oversee contract vendors to advance pharmacometric efforts and activities
Oversee and contribute to clinical pharmacology sections of clinical study protocols, SAPs, CSRs, stand-alone PK/PD reports, Clinical development plans
Author and review clinical pharmacology documents for submission and/or response to regulatory agencies
Actively identify state-of-the-art quantitative approaches in the field for potential applications to projects, including the use of artificial intelligence/machine learning (AI/ML) techniques