Insmed

Provide regulatory CMC (RA CMC) leadership and strategy to achieve regulatory approvals in various countries and collaborate closely with multiple functions within Insmed and with external CROs/CMOs. Interpret regulatory guidance and regulations from various health authorities, as well as industry and government agency best practices and trends.

Responsible for the management and oversight of phase I-IV clinical trials, with a key focus on Phase 1-2a, from start up through CSR including, but not limited to, development of project documentation, training project staff, monitoring study progress, assessing protocol adherence, administration and oversight of study budgets, monitoring oversight of site-level activities related to ongoing and planned trials, management of third-party vendors for clinical services, management of project timelines and deliverables.

Responsible for the direct management and oversight of data management activities for assigned studies. Work with the study team to ensure data review, project support, study document management and oversight of DM timelines, EDC/IWRS setup, study database design, clinical data capture, discrepancy management and data reconciliation.

As a pivotal member of the Nonclinical Safety team, the Senior Scientist, Study Toxicologist, collaborates with project toxicologists and manages the outsourcing, design, and oversight of safety pharmacology and toxicology studies at contract research organizations (CROs). This position requires a strategic and detail-oriented professional who can effectively coordinate studies and ensure high-quality data.