The Associate Director leads analytical activities across the development portfolio, ensuring all CMC documentation and data are accurate and phase-appropriate. They collaborate with Regulatory CMC, Quality, and external CDMOs to manage method development, validation, and regulatory submission documentation.
Manage the execution of medical information activities by providing accurate and compliant responses to unsolicited inquiries from healthcare professionals and patients. Oversee medical information operations, including database management, vendor coordination, and the development of standard response documents.
Provide strategic leadership and oversight for GCP quality assurance activities and audit programs to ensure clinical trial compliance. Lead regulatory inspection readiness and manage the resolution of quality events, deviations, and CAPAs.
Lead phase-appropriate small molecule drug substance development, including synthetic route selection, process optimization, and scale-up. Manage external CDMOs and author critical CMC sections for regulatory filings such as INDs and NDAs.
The Senior MSL serves as a field-based scientific expert engaging with KOLs and HCPs to support the drug candidate bezuclastinib across oncology and immunology. They are responsible for developing regional business plans, gathering clinical insights, and ensuring consistent scientific communication nationally.
The Senior MSL will manage their territory as a scientific expert in GIST and Systemic Mastocytosis, leading scientific engagement with thought leaders and HCPs to gather insights and shape strategy. This role also involves developing and executing territory strategy, supporting cross-functional teams, and contributing to education and compliance.
