Clinical Trial Manager

Описание вакансии

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 Clinical Trial Manager (CTM) is responsible for the execution, and oversight of global clinical trials, ensuring high-quality delivery in alignment with ICH-GCP, regulatory requirements, and corporate objectives. This role provides day-to-day operational management of CROs and vendors and contributes to the development of processes that support the growth of the Clinical Operations function. This position requires on site presence in the Alkeus office in Cambridge, MA.

Responsibilities

• Manage daily clinical trial operations for a global clinical trial across all trial phases (startup through closeout), ensuring adherence to timelines, budget, and quality standards.
• Coordinate cross-functional team activities, document review.
• Oversee CRO and vendors, monitor performance metrics, and ensure timely and high-quality deliverables.
• Provide monitoring oversight, including participation in co-monitoring visits, reviewing monitoring reports, confirming follow-up on action items and escalating issues.
• Support start-up activities to help accelerate site activations
• Oversee site management and site engagement initiatives to maintain strong site relationships.
• Lead study-specific meetings, including internal team meetings, CRO/vendor meetings.
• Provide input on key study documents including protocols, ICFs, eCRFs, and operational plans, etc.
• Track study timelines, enrollment, protocol deviations, data trends, and sample management in partnership with CRO and internal stakeholders.
• Support risk identification and mitigation planning efforts.
• Maintain inspection readiness and ensure compliance with SOPs and regulatory standards.
• Prepare regular study updates, presentations, and risk assessments for senior leadership.
• Contribute to process improvement initiatives, development of SOPs, and operational best practices for the Clinical Operations department.

Qualifications

• Bachelor’s degree in a scientific or health-related field required; Advanced degree preferred.
• Minimum 5 years managing clinical trials and 8+ years of industry experience.
• Experience managing outsourced global clinical trials across Phase I–III strongly preferred.
• Experience managing phase III trials is a must.
• Strong knowledge of ICH-GCP and global regulatory requirements.
• Experience in biotech/pharma environment required.
• Ability to manage multiple tasks in a fast-paced environment.

• Skills and Key Success Factors:

+ Entrepreneurship spirit with a passion to build, learn and evolve 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 with an entrepreneurial spirit

+ 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: As required

Compensation

• Base Salary Range: $140,000 - $160,000, with the actual contingent upon several factors such as the selected candidate’s education/work experience/training, and other factors (travel requirements, etc.)
• Discretionary Bonus: up to 15% of Base Salary, contingent upon meeting performance components
• Equity: initial grant of incentive stock options
• 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.