1. Manage study timelines, objectives and budgets, ensure data accuracy and integrity.
2. Analyze and interpret the data generated during discovery, early and/or full development; responsible for timely and effective communication of data, strategy and results to the project teams.
3. Identify potential project hurdles, suggest solutions and contribute to contingency plans.
4. Coauthor and prepare key preclinical and clinical, and regulatory documents, scientific manuscripts and patent application, including, but not limited to: study protocols, study reports, modeling reports, investigator brochures, IND/IMPDs and NDAs within agreed timelines, and meeting all regulatory requirements.
5. Works collaboratively within cross-departmental teams, department-wide initiatives and work streams.
6. Provide cell therapy expertise on due diligence of BD projects and prepare appropriate documentation.
7. Adhere to the appropriate SOP and GxP guidelines, and embrace a collaborative culture