Design, execute, and interpret in vitro ADME studies, including metabolic stability, CYP inhibition/induction, plasma protein binding, permeability (Caco-2/MDCK), solubility, and transporter assays.
Contribute to in vitro–in vivo correlation (IVIVC) analyses to inform candidate selection and advance structure–activity/property relationships.
Interpret metabolic soft spot and MetID data, translating findings into actionable guidance for medicinal chemistry teams.
Support CRO relationships for outsourced ADME studies, including scientific oversight of study execution and data quality review.
Support bioanalytical activities for the portfolio, including CRO-performed LC-MS/MS method development for small molecules and their metabolites across biological matrices.
Help ensure GLP-compliant bioanalytical practices for IND-enabling studies and monitor regulated bioanalysis timelines and data quality through CRO partners.
Contribute to fit-for-purpose bioanalytical approaches for induced proximity molecules, including strategies for quantifying bifunctional compounds and target engagement biomarkers.
Design and support in vivo PK studies across rodent and non-rodent species, including study design, data interpretation, and cross-program learnings.
Perform high-quality PK data analysis (NCA and compartmental) using Phoenix WinNonlin or equivalent, ensuring accurate reporting and data integrity.
Integrate PK data with pharmacology and toxicology readouts to inform candidate progression criteria and target product profiles.
Coordinate with CROs for in vivo studies, tracking scope, timelines, and scientific deliverables.
PK/PD Modeling & Simulation
Perform PK/PD modeling and simulation, including PBPK modeling (Simcyp, GastroPlus) and allometric scaling to support human PK prediction.
Apply quantitative pharmacology approaches to support translational decision-making, FIH dose selection, and clinical dose range prediction.
Use modeling and simulation to inform go/no-go decisions and communicate DMPK findings to project teams.
Present DMPK modeling results in cross-functional project team meetings.
Regulatory & IND-Enabling Work
Support DMPK execution for IND-enabling programs, including study design, drafting of study reports, and data package delivery.
Contribute to DMPK sections of IND and CTA submissions; author and review relevant study reports and document sections.
Support preparation of DMPK materials for interactions with regulatory agencies, including briefing documents.
Maintain working knowledge of current regulatory guidance (DDI, MIST, bioanalytical method validation, ICH M9/M10) and apply evolving standards.
Collaboration & Cross-Functional Contribution
Contribute to DMPK team goals and priorities in alignment with company objectives and pipeline evolution.
Serve as an active member of cross-functional project teams, contributing DMPK input to program planning and decision-making.
Support DMPK input for scientific evaluations and collaborations as needed.
Support clinical pharmacology activities as programs advance toward IND, including FIH dose projections, DDI risk assessment, and exposure–response analysis; contribute to clinical pharmacology sections of regulatory documents.
Help track CRO spend and study timelines in alignment with program milestones.
Author and present scientific findings through peer-reviewed publications, conference abstracts, and posters; contribute to General Proximity’s scientific credibility and platform visibility in the induced proximity field.