Senior Scientist, DMPK

Company: Bolt Biotherapeutics Icn.
Location: Redwood City
Posted on: January 27, 2023

Job Description:

Who We Are Bolt 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. This Position We are seeking a scientifically minded pharmacokineticist to join our preclinical pharmacokinetics (PK) and clinical pharmacology functions to provide scientific and technical hands-on support to project teams from candidate selection, IND filing to clinical development. This person will work with immunologists, tumor biologists and chemists on the DMPK of our immune-stimulating antibody conjugate molecules in discovery stage, make major contribution to IND filing, as well as work with clinicians and statisticians on the clinical PK and immunogenicity of our molecules in the clinic. We welcome pharmacokineticists with extensive preclinical development experience who would like to expand their professional horizon to clinical pharmacology; we equally welcome clinical pharmacologists who have a passion in biology and scientific research. This role will report to the VP of Development Sciences. Key Responsibilities * Collaborate and advise project teams during discovery stage to characterize, select, and advance ISAC molecules and/or monoclonal antibodies with ADME properties that are suitable to the therapeutic profiles
* Provide intellectual and technical expertise concerning preclinical PK study design, execution, data interpretation and reporting, including and not limited to concentration-time profiles of the ISAC, total antibody and linker-payload in systemic circulation, bio-distribution, metabolism of the linker-payload etc.
* Lead and participate in the evaluation of exposure-efficacy and exposure-toxicity relationship
* Actively play a critical role in the assessment of potential therapeutic window, by integrating data from in vitro and preclinical PK/PD, tox and efficacy studies, and conducting projection of PK/PD, potential safety and efficacy in human.
* Support clinical programs with clinical pharmacology and immunogenicity expertise
* Identify and employ new technologies and strategies that address current and future ADME challenges
* Manage the conduct of experiments/studies at external laboratories; review and evaluate protocols, results, and reports
* Write relevant reports and sections of in regulatory filings (i.e. IND and BLA) and IB updates
* Serve as a subject matter expert in composing responses to regulatory queries Qualifications * Ph.D. in Pharmaceutical Sciences, Biomedical Engineering, Quantitative Pharmacology or related disciplines
* Expertise in PK/PD modeling using advanced software package such as ADAPT 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 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 Icn., Redwood City , Senior Scientist, DMPK, Other , Redwood City, California