Job Description
Position Summary
This role is responsible for supporting the characterization of the clinical pharmacology profile of compounds within the Alfasigma pipeline. The Sr. Manager, Global Clinical Pharmacology serves as a key representative in cross‑functional program and study teams, contributing to the development of clinical pharmacology strategies and overseeing the execution of studies and analyses through external CROs.
The role includes contribution to regulatory documentation, presentation of PK/PD data to internal stakeholders, and involvement in scientific publications. The individual also manages outsourced pharmacometric activities, including the development and implementation of PK/PD and disease models to support data‑driven decision‑making and evaluate benefit‑risk profiles.
Principal Accountabilities
- Lead the design and execution of Phase 1 clinical pharmacology studies (e.g., SAD, MAD, bioavailability, organ impairment...