- Job Type: Full-Time
- Function: Research Sci/Assoc/Mgr
- Industry: Biotechnology
- Post Date: 09/19/2022
- Website: www.nurixtx.com
- Company Address: 1700 Owens Street, Suite 205, San Francisco, CA, 94158
About NurixNurix Therapeutics discovers drugs that harness the body's natural process to control protein levels.
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. Nurix is headquartered in San Francisco, California.
The Associate Director of clinical pharmacology will oversee clinical pharmacology efforts across early and late stage programs. As an early member of the Clinical Pharmacology organization, you will have an opportunity to influence the direction of the clinical pharmacology group at Nurix. The successful applicant be proficient in the use of innovative methods to integrate knowledge of PK and PD to optimize doses, dosage regimens and study designs. 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. The successful applicant will be influential across multiple functions including individual contributors, development program teams, and the executive team.
- 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
- PhD/PharmD degree in a field related to Pharmacokinetics with at least 5-8 years of industry or similar experience in 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
- 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)