Alkeus Pharmaceuticals, Inc.

Key Responsibilities

• • Provide scientific leadership for Phase 3 clinical trials, including contributions to overall clinical development strategy, study design, endpoint selection, and patient population definition, with a focus on rare disease and ophthalmology indications.
• • Lead or co-lead the development of pivotal study protocols, informed consent forms, and key scientific sections of regulatory documents, ensuring alignment with global regulatory expectations (FDA, EMA, and other health authorities).
• • Serve as the scientific point of contact for assigned programs, providing ongoing oversight throughout trial execution, including review of emerging data, identification of scientific risks, and interpretation of results.
• • Partner closely with clinical operations to ensure Phase 3 trials are scientifically sound, operationally feasible, and executed in accordance with protocol, timelines, and quality standards.
• • Collaborate with biostatistics and data management to support statistical analysis plans, data review activities, interim analyses (as applicable), and final interpretation of clinical outcomes.
• • Contribute to and support regulatory interactions, including preparation of briefing documents, responses to information requests, and participation in meetings with health authorities as a scientific representative of the program.
• • Lead or significantly contribute to the preparation of clinical study reports, integrated summaries, investigator brochures, external presentations, scientific content for regulatory submissions, publications, author responses to questions from health authorities and other stakeholders.
• • Support safety monitoring activities, including review and interpretation of adverse events and safety data, participation in safety review meetings, and collaboration with pharmacovigilance to ensure appropriate benefit–risk assessment for late-stage programs.
• • Provide scientific input into investigator meetings, site feasibility and selection activities, and key study communications to ensure consistency and clarity across global trial sites.
• • Mentor junior clinical scientists and contribute to the development of best practices, processes, and standards appropriate for a Phase 3–stage organization.
• • Deliver on other related projects and initiatives as assigned, with flexibility to support evolving program needs in a growing biotechnology environment.