Job Description Role Summary: The Senior Clinical Project Manager leads and manages complex clinical studies... are delivered on time, within budget, and in compliance with GCP, ICH, and FDA regulations. The Senior Clinical Project Manager...
er submission planning; support of submission activities for initial INDs, NDAs, amendments/supplements, Clinical Trial... clinical trial applications. Coordinates with Regulatory operations for submission planning of new applications, supplements...
and execute communication plans for significant pipeline milestones, including clinical trial initiations, data readouts..., compliant, and timely communications regarding clinical trial progress, results, and implications for patients and partners...
environments. Director- or Senior Manager-level leadership experience required, with direct people management responsibility... and biologics; clinical trial material development and manufacturing services; and, pharmaceutical product development. Its...