• responsible for developing clinical pharmacology strategy suitable for target product profile (TPP) and clinical development plan (CDP) • leading the design, execution, interpretation, and reporting of Phase 1 clinical pharmacology studies • serve as clinical pharmacology lead on studies and project teams • support projects at various stages of development thereby allowing the selected candidate to play an active role in drug discovery and development efforts • contribute to clinical pharmacology strategy and related clinical development plan consistent with the target product profile, program goals, and the US/international regulatory guidance/guideline of small molecule therapeutics • collaborate with DMPK and clinical research teams to define biopharmaceutics and clinical pharmacology studies needed to support an NDA and drug label • determine scope, design, plan, and analyze phase 1-4 pharmacokinetic and pharmacodynamics studies • champion model-informed drug development (MIDD) • plan, prepare, and review drug development plans and regulatory filings • provide clinical pharmacology expertise to the project team and closely collaborate with Clinical Operations, Clinical Research, Biometrics, and Bioanalysis • contribute to the design Phase 1 clinical pharmacology studies (eg, drug-drug interactions, relative bioavailability/bioequivalence, special populations, etc.) • participate in the selection of Phase 1 CROs for clinical pharmacology studies • be accountable and responsible for the analysis and interpretation of PK and PK/PD data • participate in preparation of clinical study protocol and report • prepare clinical pharmacology section of the regulatory documents (IND, IMPD, IB, NDA CTD, etc.) • respond to regulatory requests for information (RFIs) • serve as the primary Clinical Pharmacology Lead