Ellison Medical Institute ยท 1 hour ago
Senior Scientist, DMPK
Los Angeles, CA
Full-time
Onsite
Senior Level
$140K/yr - $185K/yr
5+ years expThe Ellison Medical Institute is a medical research and development center focused on innovative cancer care. They are seeking a Senior Scientist in Drug Metabolism and Pharmacokinetics to lead studies and manage partnerships that support the advancement of new molecular entities into clinical trials.
Biotechnology
Responsibilities
Lead PK/TOX and ADME Studies
Design, execute, and interpret ADME, PK, and toxicology studies (in vitro and in vivo) to characterize compound properties and support IND submission
Develop study designs aligned with FDA/EMA guidance for IND-enabling packages, including dose range finding and GLP toxicology studies
Integrate PK/TOX findings into overall development strategy and advise on risk assessment for first-in-human studies
Data Analysis and Modeling
Perform or direct PK and ADME data analysis using Phoenix WinNonlin or equivalent modeling software
Conduct human PK predictions and first-in-human dose projections to inform clinical study design
Synthesize and communicate results in cross-functional meetings to guide decision-making and clinical translation
CRO Management and Oversight
Identify, qualify, and manage CROs for ADME, PK, and toxicology studies, ensuring high-quality data delivery and adherence to GLP standards
Provide clear technical direction, review study protocols, monitor study progress, and critically assess data deliverables
Establish timelines, budgets, and deliverables for external studies and ensure alignment with regulatory milestones
Regulatory and IND Authoring
Lead the preparation and authorship of nonclinical sections (Module 2.6, 2.7.1, and 4.2) of the IND, collaborating with internal teams and external consultants as needed
Support responses to regulatory agency questions and contribute to the nonclinical components of investigator brochures and clinical protocols
Ensure that all documentation and data are audit-ready and compliant with ICH and FDA standards
Cross-Functional Collaboration
Partner with clinical, CMC, and research teams to ensure preclinical findings are effectively translated into clinical development
Provide DMPK guidance for formulation selection, route of administration, and clinical study design
Contribute to strategic discussions on candidate selection, dose justification, and safety margins
Innovation and Technology Integration
Introduce and implement innovative modeling, bioanalytical, and in silico tools to enhance predictive accuracy and program efficiency
Stay current with emerging regulatory expectations, technologies, and best practices in DMPK and toxicology
Qualification
Required
PhD in Pharmacokinetics, Toxicology, Drug Metabolism, Pharmaceutical Sciences, Pharmacology, or a related field, with 5+ years of relevant industry experience
Proven track record of designing and interpreting PK/TOX and ADME studies to support drug discovery and development
Strong understanding of GLP regulations, ICH M3 (R2), and FDA nonclinical study expectations
Experience preparing IND nonclinical modules and interacting with regulatory agencies
Proficiency with PK modeling and simulation tools (e.g., WinNonlin, GastroPlus, Simcyp)
Experience managing CROs conducting PK/TOX studies, ensuring quality, compliance, and alignment with IND-enabling requirements
Preferred
Experience working across multiple drug modalities, including small molecules and biologics
Benefits
Bonus eligibility
Comprehensive benefits package
Company
Ellison Medical Institute
Formerly known as the Ellison Institute of Technology Los Angeles, the Ellison Medical Institute strives to spark innovation, leverage technology, and drive interdisciplinary, patient-centered research to continually enhance health, reimagine and redefine cancer care, and transform lives.
51-200 employees
H1B Sponsorship
Ellison Medical Institute has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (2)
2022 (1)
2021 (4)
Funding
Current Stage
Growth StageLeadership Team
L
Lisa Flashner
Senior Strategic Advisor
Recent News
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2025-04-11
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