About the job
At Alumis Inc., we are on a mission to revolutionize the treatment landscape for patients suffering from autoimmune diseases. Despite the advancements made in the last twenty years, many individuals with immunological disorders still face challenges in their treatment journeys. Our aim is to drastically improve outcomes for these individuals.
We are currently looking for a Director of Clinical Pharmacology and DMPK who will spearhead the clinical pharmacology strategy and pharmacokinetics/pharmacodynamics (PK/PD) modeling for our small-molecule programs targeting immune-mediated diseases. This pivotal role will involve close collaboration with cross-functional teams and will report directly to the Head of Clinical Pharmacology and DMPK.
Key Responsibilities Include:
- Formulate and lead clinical pharmacology strategies, including dose selection and PK/PD biomarker planning across various stages of program development.
- Conduct and interpret pharmacokinetic (PK), PK/PD, exposure–response, and simulation analyses utilizing platforms such as NONMEM, WinNonlin, R, Python, and Simcyp.
- Integrate translational and nonclinical PK/PD data to inform first-in-human (FIH) dose projections and drug-drug interaction (DDI) assessments.
- Oversee bioanalytical contract research organizations (CROs) to ensure the delivery of high-quality PK/PD and biomarker data in compliance with GLP/GCP standards.
- Collaborate with Clinical Operations on sample management and protocol design.
- Effectively communicate quantitative findings and contribute to regulatory documentation, including protocols, Investigator's Brochures (IBs), Investigational New Drug applications (INDs), New Drug Applications (NDAs), and Investigational Medicinal Product Dossiers (IMPDs).
- Work collaboratively with Clinical Development, Biostatistics/Data Science, Nonclinical teams, and Program Management.
