What are the responsibilities and job description for the Associate Director, Clinical Pharmacology position at Nurix?
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.
Position
The Associate Director in the Clinical Pharmacology group will contribute to 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 clinical pharmacology strategy including 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.
Responsibilities
- Develop clinical pharmacology development plans, timelines and prioritization of studies
- Oversee and contribute to clinical pharmacology sections of clinical study protocols, SAPs, CSRs, stand-alone PK/PD reports, Clinical development plans
- Multidisciplinary collaborations to ensure modelling and simulation methods (e.g., QSP, MBDD, PBPK) inform internal decision making and external regulatory relations
- Foster cross functional (Clinical operations, Research, Bioanalysis, Biometrics, CMC and Clinical Sciences) collaborations to guarantee seamless implementation of Phase I-III studies
- Capable of integrating PK, PD, and safety data from multiple sources to optimize dosing for patient populations across the development continuum
- Offer input on preclinical-stage programs to augment preclinical effectiveness and biomarker data to support the progression of programs into clinical development
- Advocate for MIDD across drug discovery and development
- Actively identify state-of-the-art quantitative approaches in the field for potential applications to projects
Qualifications
- PharmD or PhD or MS in a field related to Pharmacometrics with at least 5-8 year(s) of industry or similar experience in Pharmacometrics, Clinical Pharmacology or Quantitative Systems Pharmacology
- Demonstrated exemplary PK/PD experience in managing clinical and nonclinical projects
- Current knowledge of regulatory guidances, global regulations, and SOPs in the conduct of clinical pharmacology studies
- Experience with authoring/reviewing clinical pharmacology documents for submission and/or response to regulatory agencies
- 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
- Demonstrated past performance of functioning efficiently in a dynamic, cooperative, team-oriented environment showcasing emotional intelligence (respect and empathy)
- High proficiency in using one or more of the common software and data analysis packages (e.g., R, WinNonlin, Simcyp, GastroPlus, Monolix, NONMEM)
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