Senior Scientist, DMPK

Ellison Medical Institute•Los Angeles, CA

8d•$140,000 - $185,000

About The Position

The Ellison Medical Institute is seeking an accomplished and passionate Senior Scientist in Drug Metabolism and Pharmacokinetics (DMPK) to join our Translational Biology team. In this high-impact role, you will apply your expertise in pharmacokinetics (PK), toxicology (TOX), and drug metabolism (ADME) to accelerate the advancement of groundbreaking new molecular entities as our lead compound advances into IND-enabling and first-in-human studies. This is a pivotal role in shaping the nonclinical strategy, managing CRO partnerships, and authoring the IND nonclinical modules to support regulatory filings and clinical transition. The ideal candidate thrives in a dynamic start-up environment and can balance hands-on scientific work with strategic oversight. This is a unique opportunity to be at the forefront of early-stage drug development, in a collaborative, multidisciplinary environment, where your contributions will help shape the future of medicine.

Requirements

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.

Nice To Haves

Experience working across multiple drug modalities, including small molecules and biologics, is preferred.

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.