Director, Clinical Operations
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 Director, Clinical Operations is responsible for leading and managing global, late-stage pivotal clinical trials in alignment with corporate objectives and governing regulatory guidelines. This role is key to the strategic planning, development and implementation strategies of clinical trials to ensure successful and timely execution. The role will oversee CROs and vendors ensuring successful delivery of study objectives on time, within budget, and in compliance with quality and regulatory standards. The Director, Clinical Operations plays a critical role in planning, assessing feasibility, activating sites, as well as the implementation and management acro
