About the Project:
After successfully building our biopharmaceutical client’s clinical affairs, biometrics, and quality departments, ES Pharma was brought on as a strategic partner to assist with an expanding bandwidth in the late phase of R&D for an upcoming NDA submission and further medical review. As the NDA submission and medical review processes are lengthy and require a team of experienced professionals to bring the products to market after FDA review, the client was tasked with having the product to the consumer within a year’s time.
Unique scheduling requirements: The client desired candidates who could be flexible to work part-time as a consultant, while also having the ability to work remotely from anywhere in the nation.
Exponential growth: Due to an increasing volume of medical review needs for clinical studies, the client’s internal team could no longer manage a heavy workload with the peak of reviews yet to come.
Rapid timeline: The client needed a quick onboarding process, which meant they needed to hire the right fit. With limited training resources, candidates were expected to hit the ground running.
By having a qualified candidate pool ready, the team at ES Pharma placed two contract Medical Directors: one to work full-time on patient safety reporting, and another board-certified Clinical MD to work a flexible 30-hour work week handling medical review for new and upcoming clinical studies across the active Phase 3/3b as well as upcoming Phase 1 studies. This allowed the management team to focus on strategic initiatives and move the department toward its submission-related goals.
Placed 2 Remote Contract Positions > 1 Safety Medical Director Onboarded In Under 2 Weeks > 1 Part-Time Clinical Medical Director Onboarded Within 30 Days