Qureos Mentor

Ellison Medical Institute

<div>Job Title: Senior Scientist, DMPK 
Annual Base Salary: DOE, $140,000-$185,000 along with bonus eligibility and a comprehensive benefits package 
Location: Los Angeles, CA 
 
Our Mission 
The Ellison Medical Institute, formerly known as the Ellison Institute of Technology Los Angeles, strives to spark innovation, leverage technology, and drive interdisciplinary, patient-centered research to continually enhance health, reimagine and redefine cancer care, and transform lives. 
 
Established in 2016 as a medical research and development center, the Institute features innovation labs for artificial intelligence and molecular analytics and was among the first organizations to vertically integrate the interdisciplinary study and treatment of disease. We offer multifaceted programs, including a preventative medicine and cancer clinic, cross-disciplinary research laboratories, a health policy think-tank, and community outreach and educational programs. 
 
Please visit emila.org for more details. 
 
Job Summary
 
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. 
 
Why You Should Join Us:<ul><li>
Drive Innovation: Contribute to the advancement of cutting-edge drug development and therapeutic strategies that transform patient care.</li><li>
Be at the Forefront: Work with a world-class team and integrate new technologies in PK/TOX and ADME studies to accelerate the drug discovery pipeline.</li><li>
Make an Impact: Help shape clinical trial strategies and regulatory pathways that will support the successful progression of therapeutic candidates into clinical trials.</li></ul>
Job Accountabilities:
<ul><li>Lead PK/TOX and ADME Studies<ul><li>
Design, execute, and interpret ADME, PK, and toxicology studies (in vitro and in vivo) to characterize compound properties and support IND submission.</li><li>
Develop study designs aligned with FDA/EMA guidance for IND-enabling packages, including dose range finding and GLP toxicology studies.</li><li>
Integrate PK/TOX findings into overall development strategy and advise on risk assessment for first-in-human studies.</li></ul></li><li>
Data Analysis and Modeling<ul><li>
Perform or direct PK and ADME data analysis using Phoenix WinNonlin or equivalent modeling software.</li><li>
Conduct human PK predictions and first-in-human dose projections to inform clinical study design.</li><li>
Synthesize and communicate results in cross-functional meetings to guide decision-making and clinical translation.</li></ul></li><li>
CRO Management and Oversight<ul><li>
Identify, qualify, and manage CROs for ADME, PK, and toxicology studies, ensuring high-quality data delivery and adherence to GLP standards.</li><li>
Provide clear technical direction, review study protocols, monitor study progress, and critically assess data deliverables.</li><li>
Establish timelines, budgets, and deliverables for external studies and ensure alignment with regulatory milestones.</li></ul></li><li>
Regulatory and IND Authoring<ul><li>
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.</li><li>
Support responses to regulatory agency questions and contribute to the nonclinical components of investigator brochures and clinical protocols.</li><li>
Ensure that all documentation and data are audit-ready and compliant with ICH and FDA standards.</li></ul></li><li>
Cross-Functional Collaboration<ul><li>
Partner with clinical, CMC, and research teams to ensure preclinical findings are effectively translated into clinical development.</li><li>
Provide DMPK guidance for formulation selection, route of administration, and clinical study design.</li><li>
Contribute to strategic discussions on candidate selection, dose justification, and safety margins.</li></ul></li><li>
Innovation and Technology Integration<ul><li>
Introduce and implement innovative modeling, bioanalytical, and in silico tools to enhance predictive accuracy and program efficiency.</li><li>
Stay current with emerging regulatory expectations, technologies, and best practices in DMPK and toxicology.</li></ul></li></ul>
ADDITIONAL INFORMATION
 
Required Education &amp; Experience:<ul><li>
PhD in Pharmacokinetics, Toxicology, Drug Metabolism, Pharmaceutical Sciences, Pharmacology, or a related field, with 5+ years of relevant industry experience.</li><li>
Proven track record of designing and interpreting PK/TOX and ADME studies to support drug discovery and development.</li><li>
Strong understanding of GLP regulations, ICH M3 (R2), and FDA nonclinical study expectations.</li><li>
Experience preparing IND nonclinical modules and interacting with regulatory agencies.</li><li>
Proficiency with PK modeling and simulation tools (e.g., WinNonlin, GastroPlus, Simcyp).</li><li>
Experience managing CROs conducting PK/TOX studies, ensuring quality, compliance, and alignment with IND-enabling requirements.</li><li>
Experience working across multiple drug modalities, including small molecules and biologics, is preferred.</li></ul>
For the safety and health of employees, guests, and patients, the Ellison Medical Institute may mandate vaccination requirements for employment. The Ellison Medical Institute's policies are always subject to review and change to ensure they are appropriate under the circumstances. 
 
The Ellison Medical Institute is an equal opportunity employer. We believe that an inclusive, collaborative team environment is just as important to our mission as stethoscopes and microscopes. We strive to always provide employees a supportive atmosphere, so they feel confident taking creative risks toward innovation. The Ellison Medical Institute values emotional intelligence and communication with empathy and respect for others. We seek to build a diverse group of people who are curious, have a deep sense of responsibility, and the grit needed to achieve excellence.
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Senior Scientist, DMPK

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Ellison Medical Institute

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Senior Scientist, DMPK