Vice President, 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.

We are seeking a people focused and accomplished leader to join our team as Vice President Clinical Operations to lead and expand the companys clinical operations capabilities supporting clinical programs in retinal diseases.

Position Summary

TheVice President Clinical Operationsrole is a key leadership position responsible for the strategic planning execution and oversight of global clinical trials with particular focus on Phase 3 and other late-stage studies.

This individual plays a critical role in ensuring operational excellence across the clinical development portfolio including the successful delivery of pivotal clinical trials supporting global regulatory filings. The Vice President will lead and mentor a clinical operations team collaborate cross-functionally across the R&D organization and oversee external partners to ensure clinical studies are executed efficiently ethically and in full compliance with regulatory standards and Good Clinical Practice (GCP).

As a senior leader in R&D this individual contributes to clinical development strategy and cross-functional planning whilerepresentingClinical Operations internally with leadership and externally with investigators CRO partners and other clinical stakeholders.

Primary Responsibilities

• Develop clinical operations strategies and implementation plans in partnership with internal and external stakeholders to support the companys clinical development goals.

• Lead the planning initiation and execution of global clinical trials across multiple programs with particular focus on Phase 3 and other pivotal studies.

• Build and lead a high performing clinical operations organization mentoring team members and fostering a collaborative and accountable culture.

• Leadrelationships with external partners including CROs central laboratories and other vendors ensuring effective vendor selection governance and performance management.

• Ensure the successful operational execution of clinical studiesin accordance withstudy protocols timelines budgets and regulatory requirements.

• Collaborate closely with Clinical Development leadership to translate clinical strategy into operationallyfeasiblestudy designs and execution plans.

• Participate in cross-functional teams for assigned programs partnering with Clinical Development Regulatory Affairs Biostatistics Data Management Safety and Medical Affairs to achieve high-quality study execution.

• Ensure compliance with global regulatory standards and guidelines governing clinical trials including Good Clinical Practice (GCP).

• Provide operational input into clinical study protocols feasibility assessments site selection strategies and patient recruitment and retention plans.

• Oversee clinical trial budgets and resource planning ensuring efficientutilizationof resources and alignment with company priorities.

• Identifyoperational risks and implement mitigation strategies to ensuretimelytrial execution and data quality.

• Support regulatory submissions and inspections by ensuring operational documentation and trial conduct meet regulatory expectations.

• Present clinical operations strategies study progress and operational updates to senior leadership and other stakeholders.

• Deliver on other related projects as assigned.

Qualifications

• Education and Certification:

• Bachelors degree in a scientific or healthcare related field;advancedegree preferred.

• Work Experience

• 12 years of experience in clinical research and clinical operations within the pharmaceutical or biotechnology industry.

• Demonstrated leadership in global clinical trial execution including operational oversight of Phase 3 or other pivotal trials.

• Proventrack recordof leading clinical operations teams and managing complex global clinical programs.

• Extensive experience managing CRO partnerships and other external vendors supporting clinical trials.

• Strong knowledge of global regulatory requirements governing clinical trials including Good Clinical Practice (GCP).

• Experience supporting regulatory submissions and inspections related to clinical trials.

• Experience contributing to clinical development plans and cross-functional program strategy.

• Experience in rare disease and/or ophthalmology drug development preferred.

• Ability to adapt to changing circumstances and industry trends.

• Significant experiencein leading and managing clinical operations teams.

• 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:able to travel up to35%of time

Compensation

• Base Salary Range: $300K - $320K with the actual contingent upon several factors such as the selected candidates education/work experience/training and other factors (travel requirements etc.)
• Discretionary Bonus: up to 30% 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.