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 Senior Director of Clinical Pharmacology (CP) will oversee CP efforts across clinical development. As an early member of the CP function, you will have an opportunity to influence the direction of the CP function at Nurix. As a CP lead, you will provide subject matter expertise and program-level functional and operational leadership to the clinical development team(s) on all issues related to CP. You will develop and manage CP strategies including quantitative pharmacology plans and model-informed drug development strategies as appropriate (population analyses, exposure-response, PBPK, QSP, etc).

The successful applicant is proficient in the use of innovative methods to integrate knowledge of PK and PD to optimize posology for early and late-stage clinical trials while collaborating with clinicians, clinical operations, bioanalytical, biomarker, pharmacovigilance, regulatory, and CMC groups. In addition, this individual will work closely with the project team to create clinical development plans that include assessments of a drug’s efficacy, safety, commercial viability and fulfillment of registration requirements. This role requires strong communication and interpersonal skills and involves leading a team of scientists to develop and manage CP strategy for compounds from pre-clinical to post-marketing approval.

Responsibilities

• Develop CP development plans, timelines and prioritization of studies
• Oversee and contribute to CP sections of clinical study protocols, SAPs, CSRs, stand-alone PK/PD reports, Clinical development plans, Regulatory documents
• Multidisciplinary collaborations to ensure modelling and simulation methods (e.g., QSP, MIDD, PBPK) inform internal decision making and external regulatory relations
• Foster cross functional (Clinical operations, Research, Bioanalysis, Biometrics, CMC, Regulatory, 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

Qualifications

• PhD/PharmD degree in a field related to Pharmacokinetics with at least 12+ years of industry or similar experience in CP or Quantitative Systems Pharmacology
• Demonstrated exemplary PK/PD experience in managing clinical and nonclinical projects; and interactions with global regulatory agencies for NDA
• Proven record of implementing MIDD approaches (e.g., BE, DDI, biowaivers)
• Current knowledge of regulatory guidance, global regulations, and SOPs in the conduct of clinical pharmacology studies
• 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 common software and data analysis packages (e.g., WinNonlin, Simcyp, GastroPlus, GraphPad Prism, Microsoft Office, PowerPoint, Excel, Word)

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