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Senior/Executive Director, Pharmaceutical Development

Employer
Nurix Therapeutics
Location
San Francisco, CA
Start date
Nov 12, 2022

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Job Details


Company

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.


Position

The candidate will build and lead a group responsible for pharmaceutical development-related activities across the portfolio including pre-formulation, formulations to support research, formulation and manufacture and supply of clinical trial materials, characterization of formulation and associated manufacturing process to support NDA filing and supporting commercial manufacturing. The ideal candidate will be a highly motivated leader with experience and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities.

Principal Duties and Responsibilities

  • Overall responsibility for all drug product related activities, including formulations of test articles to support candidate selection during drug discovery, from preclinical development through commercialization
  • Identification, selection, and management of Contract Manufacturing Organizations (CMOs) for process optimization, formulation development and cGMP manufacture of Drug Product (DP) in support of ongoing clinical programs
  • Delivery of robust, scalable, and cost-effective manufacturing routes and drug product formulations that meet or exceed the target clinical profile
  • Implement stage appropriate process characterization, identify critical quality attributes, and implement controls to ensure that all CROs and CMOs are using systems and processes in compliance with all relevant regulatory standards and to ensure consistency of product performance
  • Projection of DP needs for preclinical and clinical programs (with supply chain and clinical team), and associated budgets (with finance team)
  • Management of supply chain and logistics in support of clinical studies
  • Develop and execute plans for the primary stability registration and validation batches of DP as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations
  • Prepare and/or review CMC sections of INDs, CTAs, NDAs, MAAs and other regulatory submissions; represent the company as the DP expert before U.S. and European regulatory authorities
  • Prepare, review, or edit cGMP batch records, CMC regulatory and Quality documents
  • Prepare technical reports, publications, and oral presentations

Skills and Background

  • PhD or MS with 15+ years of experience; Advanced degree in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or related scientific discipline
  • At least 10 years relevant experience in a pharmaceutical or biotechnology CMC/cGMP environment
  • Substantial experience leveraging US and International CRO/CMOs for the manufacture of cGMP DP to meet aggressive timelines
  • Substantial experience with projects in clinical development (e.g., Phase 1 through Phase 3 including multiple pharmaceutical dosage forms such as tablets, capsules, topicals, etc.)
  • Experienced with cGMP manufacturing and IND, CTA, and NDA filings; thorough knowledge of relevant FDA and EMEA regulations
  • Experience in supply chain management.
  • Able to identify and resolve critical issues
  • Experience implementing technical, strategic, and operational plans
  • Excellent written and verbal communication skills, exceptional interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators)
  • Qualities of servant leadership and self-awareness required

Nurix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or genetics. In addition to federal law requirements, Nurix complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training. Nurix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, or veteran status. Improper interference with the ability of Nurix’s employees to perform their job duties may result in discipline up to and including discharge.

Company

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.

Company info
Website
Phone
415-660-5320
Location
1700 Owens Street
Suite 205
San Francisco
California
94158
US

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