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