Director/Sr. Director, Clinical Pharmacology
The director of clinical pharmacology will lead clinical pharmacology efforts across multiple early and late clinical stage programs. As the founding 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 pharmacokinetics (PK), biopharmaceutics, pharmacodynamics, patient characteristics and disease states 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.
- Liaise with preclinical development teams to assist in the interpretation of preclinical data and extrapolation of implications for human clinical development
- Provide scientific leadership on clinical pharmacology and guide dose regimen/optimization strategies in partnership with other therapeutic area leads to enable data-driven decisions for multiple development programs
- Provide technical input and authoring of regulatory submissions related to all aspects of clinical pharmacology (including protocols, PK reports, INDs, NDAs, MAAs) and responses to regulatory questions.
- Participate in meetings and interactions with regulatory agencies involving clinical PK and pharmacology questions.
- Lead the design and execution of the clinical pharmacology component of drug development programs including exposure-response, population PK/PD analyses, and develop high quality modeling and simulation strategy and content for global regulatory submissions
- Manage PK vendors and contractors including review of PK analysis plans and PK reports for clinical studies
- Highly motivated and self-driven individual with the ability to work independently, multi-task, and adhere to aggressive timelines in support of department and corporate objectives.
Education and Experience
- An advanced degree (PhD, or PharmD) in pharmacology, pharmaceutical sciences, pharmacy, life sciences, or other related fields with a minimum of 8 years relevant experience in the biotech/pharmaceutical industry
- Expertise in PK/PD data analysis, and popPK data interpretation and other modeling or data visualization software
- Confirmed knowledge of all phases of drug development, multi-region requirements including regulatory aspects, compliance, processes and pharmacometrics activities as it relates to PK/PD analysis.
- In depth understanding of designing, leading, conducting and analyzing clinical pharmacology/PK studies in humans including and an in depth understanding of PK/PD, drug metabolism and clinical research concepts
- Strong theoretical background and hands-on experience interpreting clinical dose-response and PK/PD, and in silico data to inform clinical study designs and drug development decision-making
- Excellent oral and written communication skills and a proven track record of working effectively in a dynamic, collaborative, fast paced, team-oriented environment
Fit With Nurix Culture
- Ability to build strong relationships with co-workers of various backgrounds and expertise
- Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
- Values-based leadership consistent with Nurix's Core Values
- Excitement about the vision and mission of Nurix
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.