Vice President, Clinical Development

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

We are seeking a people focused and accomplished leader to join our team as the Vice President, Clinical Development to lead and expand the company’s clinical programs in retinal diseases. This role is a key leadership position responsible for the strategic planning, execution, and oversight of all clinical development programs, ensuring alignment with regulatory standards and company goals. This individual plays a critical role in shaping the clinical strategy, ensuring scientific rigor, regulatory compliance, and the timely progression of our pipeline and interactions with health authorities, board, investors, analysts, patient advocacy groups, retina specialists, and other stakeholders.

This individual also leads and mentors a team of clinical development professionals, collaborates cross-functionally, and represents the company externally with key opinion leaders, investigators, and regulatory bodies.

• Develop clinical strategies and implementation plans, in partnership with both internal and external resources to achieve the company’s strategic and operational goals.
• Lead assigned clinical development team members across multiple clinical programs.
• Oversee the review, analysis and interpretation of clinical trial data and the reporting of clinical trial results, including preparation of abstracts, presentations, and manuscripts.
• As a senior leader in R&D, contribute to corporate strategy, investor relations, and business development initiatives.
• Lead interactions with KOLs, advisory boards, and external stakeholders to guide study designs and development plans.
• Participate in cross-functional teams, as needed, for assigned trials, collaborating with other team members to achieve efficient, high-quality study execution.
• Provide input on regulatory strategies, reviewing, and approving where necessary, regulatory documents for submission to multiple regulatory agencies for the various clinical programs.
• Lead interactions with academic thought leaders, investigators, cooperative groups, pharmaceutical partners/sponsors, patient advocacy groups, and other clinical stakeholders, developing relationships in support of clinical programs. Furthermore, engage in scientific and medical exchanges and identify unmet medical needs and gaps.
• Ensure appropriate management and oversight of clinical studies in partnership with clinical operations leadership. This includes, but is not limited to, the development of clinical study protocols; contribute to the selection and management of external partners such as CROs and other vendors; provide input on site selection for studies, study management, medical monitoring, clinical study reports, investigators brochures, regulatory briefing documents, and clinical sections of regulatory filings.
• Support clinical study teams, monitoring the overall study integrity, and reviewing, interpreting, and communicating accumulated data pertaining to safety and efficacy of the molecule.
• Present at scientific, medical, and regulatory meetings globally.
• Manage assigned budget, ensuring efficient resource utilization and investment in the areas of highest impact.
• Deliver on other related projects as assigned.

• Education and Certification
• Advance degree required; MD, MD/PhD, or equivalent a plus; specialty training or experience in Ophthalmology is preferred.
• Subspecialty training or deep experience in retina preferred.
• Work Experience
• 5+ years of clinical development experience in the…