Senior Clinical Scientist

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.

The Senior Clinical Scientist is responsible for providing scientific leadership and oversight for late‑stage (Phase
3) clinical development programs in rare disease ophthalmology. This role plays a critical part in ensuring the scientific integrity, regulatory readiness, and successful execution of pivotal clinical trials intended to support global registration. As a senior individual contributor, the Senior Clinical Scientist serves as a core scientific partner across clinical development, working closely with clinical operations, biostatistics, regulatory affairs, and safety to translate strategy into executable, high‑quality Phase 3 studies.

This role is well‑suited for an experienced hire with demonstrated success in late‑stage clinical development within rare disease and/or ophthalmology.

• 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.

• Education and Certification
  • Master’s or Ph.D. in a relevant scientific discipline required; M.D. strongly preferred
• Work Experience
  • 6–10+ years of experience in clinical research, pharmaceutical, or biotechnology settings
  • Demonstrated experience supporting or leading Phase 3 clinical…