Manager II, Clinical Studies
Alkeus Pharmaceuticals, Inc. is a clinical-stage biotech company focused on the development of innovative therapies to treat serious diseases of the eye with high unmet need. Based in Cambridge, Mass., Alkeus was founded in 2010, and since that time has been developing its lead compound, gildeuretinol acetate (ALK-001). Designated as a breakthrough therapy and granted orphan drug status by the U.S. Food and Drug Administration, gildeuretinol is being evaluated in multiple clinical trials for the treatment of Stargardt disease and geographic atrophy (GA) secondary to age-related macular degeneration (AMD), a leading cause of blindness in the U.S.
Position Summary:
The Manager II, Clinical Studies provides strategic and operational leadership for assigned clinical studies from study planning and start-up through execution, database lock, closeout, and archival. The Manager II, Clinical Studies is accountable for the successful operational delivery of assigned studies, ensuring that timelines, budgets, quality standards, and key study objectives are achieved.
Working closely with Clinical Development, Clinical Science, Data Management, Biostatistics, Regulatory Affairs, Drug Safety, Quality Assurance, Clinical Supply, and other functions, the Sr. CSM ensures coordinated and compliant execution of clinical studies in accordance with
