The Safety-PV Operations Lead will develop and manage global safety operations, including vendor oversight and the creation of core safety documents. This role involves close collaboration with the Head of Global Medical Safety to ensure regulatory compliance and effective signal management across clinical programs.
Lead end-to-end GCP quality for clinical development, ensuring compliance from study start-up through inspection readiness. Provide quality oversight for pharmacovigilance (GVP) and pre-clinical (GLP) activities while managing relationships with CROs and regulatory authorities.
The Medical Science Liaison will serve as a scientific expert, building partnerships with neurologists and care teams to support clinical trials and programs. They are responsible for KOL engagement, scientific communication, and providing medical affairs support across cross-functional teams.