Manisha Bairad

Lead imaging strategy for Phase I/II radioligand therapy trials, accelerating decision-making and improving data quality. Design imaging charters, endpoints, and BICR frameworks to ensure consistency and regulatory compliance. Oversee dosimetry, biodistribution, and PET/CT and SPECT integration into clinical and regulatory plans. Manage CROs, vendors, and budgets, driving cost efficiency, risk mitigation, and on-time execution across cross-functional teams globally.

Managed 9 international Oncology clinical trials with imaging, ensuring high-quality data and oversight. Directed centralized imaging operations, including site qualification and standardized acquisition protocols. Oversaw core lab performance, data reconciliation, and QC workflows to drive consistency. Led RECIST-based tumor assessments, imaging feasibility, and modality strategy. Managed governance, cross-functional coordination, scope control, and financial forecasting, ensuring inspection readiness

- Coordinated study operations from initiation through close-out. - Ensured compliance with imaging acquisition protocols and data quality standards. -Supported centralized imaging review and regulatory documentation processes.