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 across all phases of assigned studies.

Primary Responsibilities

● Manage the day-to-day clinical trial operations and execution of assigned studies while partnering with cross-functional teams to inform and support the broader clinical development strategy across all phases of the clinical program.

● Provide end-to-end oversight of pivotal trials, ensuring timely progression through all phases including initiation, enrollment, monitoring, and study closeout.

● Develop and maintain project plans, and performance dashboards to proactively manage risk and ensure operational targets are met.

● Ensure all trial activities adhere to applicable global regulatory and ethical standards (i.e. GCP, ICH, etc.) to support audit readiness and safeguard data integrity.

● Monitor vendor activities against contractual obligations, escalating issues as needed to maintain quality and timeline commitments.

● Act as the primary operational point of contact across internal teams (including Data Management, Biostatistics, PV/Safety, Clinical Development, Medical Monitor, etc.), driving alignment and collaboration to ensure cohesive study execution.

● Oversee the site identification and activation process, alongside the CRO and clinical team, while closely monitoring site performance to support enrollment and data quality.

● Manage resolution of site-level issues to identify root causes and implement corrective actions to minimize disruptions to study conduct, including enrollment challenges and protocol deviations.

● Provide operational input during the design and development of study documentation, including study-specific plans, to ensure feasibility and alignment with regulatory standards and the trial protocol.

● Ensure documentation completeness for the TMF (and ISF, as applicable) and process compliance to support submissions, sponsor audits, and regulatory inspections.

● Champion corss-funtional knowledge-exchange and continuous improvement initiatives to enhance operational efficiency and consistency across programs.

● Deliver on other related projects as assigned.

Qualifications

● Education and Certification

○ BA/BS degree with 10+ years of clinical trial management experience or advanced degree (MS/PhD/PharmD) in a related field with at least 7+years of clinical trial management experience.

● Work Experience

○ Minimum of -10 years of progressive experience in clinical research and drug development in the pharmaceutical industry including 7+ years of direct experience in clinical operations trial management/leadership in global, late-stage trials.

○ Experience with CRO/vendor selection and management.

○ Demonstrated ability to work independently and drive projects to completion.

○ Working experience in rare disease and/or ophthalmology drugs a plus.

○ Strong command of GXP requirements and ICH/GCP guidelines and global clinical trial regulations.

○ Strong analytical and technical skills, including proficiency in project management practices, project planning, and decision-making.

○ Clear communication skills with ability to articulate complex strategic considerations and influence discussions to address challenges and reach decisions.

●Skills and Key Success Factors

○ Entrepreneurial mindset with a passion for building, learning and growing with the team

○ Highly organized and detail oriented with a passion to deliver quality results

○ Excellent verbal and written communication skills, with experience translating complex concepts for various audiences

○ Demonstrated record of intellectual curiosity, innovation and creative problem solving

○ Ability to lead fast-paced projects with a keen sense of urgency to get the job done well

○ Evidence of "hands-on" experience and expertise

○ Proven and successful track record as a team-player and collaborator in small working environments

○ Highest levels of professionalism, confidence, personal values and ethical standards

Other Relevant Information

Travel: able to travel up to 25% of time

Compensation

o Base Salary Range: $190,000 - $220,000, with the actual contingent upon several factors such as the selected candidate’s education/work experience/training, and other factors (travel requirements, etc.)

o Discretionary Bonus: up to 20% of Base Salary, contingent upon meeting performance components

o Benefits: Eligible to participate in group medical/dental/vision insurance plans; short- and long-term disability plans; life insurance; 401(K) plan; flexible time off policies and others. Eligibility and participation requirements vary by plan.

_Alkeus Pharmaceuticals, Inc. is an equal opportunity employer and considers all qualified applicants for employment without regard to any characteristic protected by applicable law. We participate in E-Verify and conduct background checks as a part of our employment process._