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Associate Director, Clinical Data Management

Cambridge, MA

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 Associate Director of Clinical Data Management (AD CDM) will lead and oversee end-to-end data management activities across multiple clinical studies. This role requires strong hands-on experience in clinical data management, CRO/vendor oversight, process optimization, and inspection readiness. The AD CDM will also leverage clinical programming tools such as Power Query or any other clinical programming tools to support data analysis, visualization, and reporting. The ideal candidate must be able to work independently on assigned studies while collaborating cross-functionally to ensure high-quality, regulatory-compliant clinical trial data to support study execution and submission.

Primary Responsibilities:

Clinical Data Management & Study Execution

  • Provide hands-on oversight of end-to-end clinical data management (DM) activities from study start-up to database lock, ensuring compliance with regulatory requirements and company SOPs.
  • Lead data review, query management, reconciliation (SAE, central lab, PK, etc.), and data quality control activities.
  • Ensure timely and high-quality database build, user acceptance testing (UAT), and validation of EDC systems.
  • Implement and maintain efficient, standardized DM processes across studies.

CRO/Vendor Oversight & Collaboration

  • Serve as the primary point of contact for CROs and external vendors, ensuring adherence to contractual deliverables, timelines, and quality standards.
  • Review CRO/vendor performance metrics, key quality indicators (KQIs), and risk management plans.
  • Collaborate with internal stakeholders (Clinical Operations, Biostatistics, Medical, Safety) to resolve data issues and optimize study execution.

Process Improvement & Inspection Readiness

  • Ensure DM processes align with regulatory requirements (FDA, EMA, ICH-GCP) and are audit/inspection-ready.
  • Develop and implement quality control measures, risk-based monitoring, and data integrity initiatives.
  • Lead DM contributions to regulatory inspections and audits, preparing documentation and addressing findings.
  • Drive process optimization, automation, and adoption of new technologies to enhance data management efficiency.

Stakeholder & Team Collaboration

  • Act as a key CDM representative in cross-functional study teams, providing strategic input and expert guidance.
  • Facilitate effective communication across departments to ensure seamless study execution.
  • Provide mentorship and training to junior data management staff.

Clinical Programming & Data Analysis

  • Utilize JReview (JR), Power Query, or other clinical programming tools to generate reports, data listings, and visualizations for data review and decision-making.
  • Develop and optimize customized reports and dashboards for clinical study teams to monitor data trends and identify potential issues.
  • Enhance efficiency by automating data extraction, transformation, and reporting workflows.

Skills and Qualifications:

Required:

  • Bachelor's or Master’s degree in Life Sciences, Computer Science, or a related field.
  • 10+ years of clinical data management experience in the pharmaceutical/biotech industry, with at least 3 years in a leadership role.
  • Strong hands-on expertise in EDC systems (e.g., Medidata Rave, Veeva), clinical data visualization tools for data review and clinical data management systems (CDMS).
  • Proven experience managing CROs and vendors for outsourced clinical trials.
  • Demonstrated knowledge of regulatory guidelines (FDA, EMA, ICH-GCP) and data standards (CDISC, SDTM).
  • Expertise in handling database locks, study close-out, and data reconciliation activities.
  • Experience in preparing for and participating in regulatory inspections (FDA, EMA).
  • Strong problem-solving skills with the ability to manage multiple studies in a fast-paced environment.
  • Excellent communication, collaboration, and leadership skills.

Preferred:

  • Experience with risk-based quality management (RBQM) and centralized monitoring approaches.
  • Familiarity with clinical analytics, automation, and AI-driven data management tools.
  • Good experience in developing data review reports using Power Query.
  • Ability to drive process improvement initiatives in a dynamic 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.
  • 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.
  • Ability and aptitude to manage ambiguity and adaptability to change.
  • Emphasize the need for self-motivation and the ability to work independently.

Other Relevant Information:

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 celebrate diversity and are committed to creating an inclusive environment for all employees.

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