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Director, Toxicology

Company: Bolt Biotherapeutics
Location: Redwood City
Posted on: January 25, 2023

Job Description:

Who We AreBolt Biotherapeutics, based in the San Francisco Bay Area, is a clinical-stage biotechnology company developing Boltbody Immune-stimulating Antibody Conjugates (ISACs), a new class of immuno-oncology therapeutics. This is a unique opportunity to join and build, with like-minded colleagues, a company that will transform the lives of individuals with cancers.The PositionWe are seeking a scientifically minded toxicologist to join our Preclinical Safety Assessment function to provide scientific and hands-on support to our immune-stimulating antibody conjugate (ISAC) drug development programs, from target validation, candidate selection, IND filing through clinical stages. The incumbent will work with immunologists, tumor biologists, chemists, DMPK and clinicians on several cancer drug development programs over a wide range of development stages, be the in-house expert on toxicology investigations and regulatory reporting while utilizing appropriate external resources. We welcome pathologists who would like to expand their professional horizon to preclinical toxicology and regulatory filing. We equally welcome toxicologists who have a passion in biology and scientific research. This role will report to the Vice President, Development Sciences.Key ResponsibilitiesServe as Preclinical Safety Assessment project team representative on multi-disciplinary Discovery and Development teams responsible for the progression of both ISAC and monoclonal antibody biotherapeutics. These activities include:--- Support Discovery projects through the development of exploratory toxicology strategy and its execution--- Design preclinical safety assessment strategy, including in vitro, in vivo and ex vivo testing--- Design and interpret safety pharmacology and toxicity studies by coordinating internal and external resources--- Active member on project teams--- Prepare and/or review safety pharmacology and toxicology reports--- Author the nonclinical document sections for regulatory submissions (including CIBs INDs, MAAs, CTAs, CTDs and BLAs)--- Participate in issue-resolution teams, where they will be required to contribute to hypotheses generation and drive the science for toxicology issue resolution in drug discovery and development--- Participate in special projects or inter-industry working groups, as needed--- Provide scientific input on design and analysis of research activities--- Identify and leverage external experts in scientific issues related to nonclinical safety assessment--- Ensure high scientific standards and adhering to requested timelines in all aspects of the positionQualifications --- Ph.D. or equivalent in pathology, toxicology, or related disciplines--- DACVP DABT or DVM is highly preferred--- 6+ years of industry experience with biologics focuses; experience in immunology and cancer immunology is highly valued; experience in ADC development is valued; experience in immunogenicity of biologics is also valued--- Inter-departmental research interests and the ability to initiate, collaborate and lead teams to address scientific issues--- Experience in interacting with the US and/or international health authorities--- Familiarity with GLP regulations preferred We are an Equal Opportunity Employer offering a competitive salary and benefits package. Applicants should be legally entitled to work for any employer in the US. Bolt Biotherapeutics requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Bolt will consider requests for Reasonable Accommodations. Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.

Keywords: Bolt Biotherapeutics, Redwood City , Director, Toxicology, Executive , Redwood City, California

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