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Senior Director/Executive Director, Toxicology/Preclinical Safety

Company: Amunix Pharmaceuticals
Location: San Francisco
Posted on: May 16, 2022

Job Description:

Senior Director/Executive Director, Toxicology/Preclinical Safety Research & Development South San Francisco, California We are seeking an experienced nonclinical safety pharmacology and toxicology scientific leader reporting to the Chief Scientific Officer. The title will be commensurate with leadership experience. This position requires strong intellectual leadership, working across discovery and development teams, and will serve as the nonclinical subject matter expert. The incumbent will design, conduct, and interpret nonclinical toxicology and investigational primate safety studies including exploratory, pilot, and pivotal, will advise management on the toxicological aspects of the project, and will effectively communicate with worldwide regulatory agencies to bring our immune oncology drugs to patients as quickly as possible. This is an ideal position for a highly motivated, interactive, and creative individual that has demonstrated expertise in toxicology supporting immune drug development, recent US and ex-US regulatory FIH submissions, and a passion for growth and learning in our fast-paced, collaborative work environment. ESSENTIAL FUNCTIONS

  • Lead toxicology/preclinical safety strategy for the Amunix pipeline of immune oncology drugs
  • Lead toxicology safety assessment activities related to drug discovery, drug development, regulatory, and marketing commitments
  • Lead the design and implementation of NHP studies in collaboration with CROs
  • Manage collaborations with study directors to support writing of study protocols, amendments, and study reports for non-GLP and GLP studies
  • Analyze, interpret, summarize, and present nonclinical safety data, both interim and final to internal teams and leadership
  • Lead investigative efforts into mechanisms of toxicity as needed
  • Develop and implement target de-risking and screening strategies in discovery teams to support safety lead optimization efforts
  • Author toxicology and safety pharmacology sections and contribute to efficacy and safety sections of global regulatory documents (INDs, NDAs, BLAs and CTDs) QUALIFICATIONS
    • PhD or DVM (DABT preferred) with 10+ years of relevant technical experience in Toxicology in the Pharmaceutical Industry and/or drug development
    • Prior experience with immune oncology biologics preferred
    • Strong scientific background and scientific aptitude
    • Proactive, enthusiastic, able to work in a fast-paced environment and make quick, but thoughtful decisions
    • Ability to work independently and direct day to day responsibilities supporting primate studies
    • Excellent record keeping, data analysis, and critical thinking skills
    • Strong organizational skills, attention to detail, and time-management skills enabling efficiency and independence
    • Able to manage multiple projects in a regulated environment
    • A team player with excellent verbal and written communication skills
    • Proficient in relevant software & computer skills
    • Proven flexibility to deal with changing timelines, shifting work priorities
    • Previous experience in drug discovery and with T cell targeted agents
    • INDs, BLAs and NDAs experience
    • Expertise in Good Laboratory Practices ABOUT AMUNIX Amunix is leveraging our expertise in precision protein engineering to enable the promise of T cell engagers in solid tumors. Our goal is to save cancer patients' lives through the development and commercialization of breakthrough therapies that harness the immune system. We have invented XTEN, a validated therapeutic half-life extension technology. Our current focus is Pro-XTEN, a next-generation protease activated pro-drug platform, which enables selective activation of potent cancer therapies in the tumor microenvironment. This overcomes a common challenge facing potent immune system activators: on-target, off-tumor toxicity. Amunix's two lead programs employ the Pro-XTEN technology to enhance the safety profile of T cell engagers. XPATs (XTENylated Protease-Activated T Cell Engagers) have the potential to make off-the-shelf therapies redirecting T cells to solid tumors a reality. Amunix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Amunix 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. You have been redirected to a Amunix Pharmaceuticals job page

Keywords: Amunix Pharmaceuticals, San Francisco , Senior Director/Executive Director, Toxicology/Preclinical Safety, Executive , San Francisco, California

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