The Director of Analytical Development manages the development and tracking of testing methodologies for drug substances and products while coordinating with internal teams and external CROs/CMOs. They are responsible for ensuring analytical activities align with project objectives, supporting regulatory filings, and overseeing stability tracking and method validation.
The Commercialization Project Manager drives product commercialization activities within the supply chain, acting as the primary link between packaging and regulatory departments. They are responsible for managing change controls, supporting product variation management, and ensuring the synchronization of regulatory and artwork timelines.
Provide strategic pharmaceutical development guidance as the CMC lead for cross-functional project teams. Manage formulation development, clinical supply, and external vendor relationships to ensure compliance and timely regulatory submissions.
Lead statistical genetics analyses of population-scale genomics data to inform business opportunities and internal development programs. Collaborate with cross-functional teams to translate analytical findings into actionable insights for target identification and clinical development.
Lead the development and execution of strategic KOL engagement plans to support the commercial launch of Infigratinib for achondroplasia. Collaborate cross-functionally to manage speaker bureaus, advisory boards, and the identification of key stakeholders in the cardiology and rare disease space.
The Associate Director will lead field medical initiatives and collaborate with experts to drive advancements in rare disease treatments. This role involves defining strategic objectives and empowering teams to innovate.
The Senior Manager will oversee SAP FICO, Group Reporting, and BTP support activities, ensuring timely resolution of issues and maintaining system compliance. This role also involves managing the integration between SAP and Coupa, driving continuous improvement within finance applications.
