Senior Director, Clinical Data Management

• SENIOR DIRECTOR, CLINICAL DATA MANAGEMENT
• Elion Therapeutics

Reports to: Executive Vice President, Clinical Operations

THE COMPANY

• Elion Therapeutics is a clinical-stage biotechnology company headquartered in Boston with a second hub in San Diego, working to meet the needs of the growing population of immunocompromised people who require therapies to effectively treat infection. The company brings together a world-class team of drug developers, including experts behind nearly every antifungal therapy approved over the past two decades and the most recently approved agent in the class. For immunocompromised people, an otherwise manageable infection can mean life or death.
• Named for Gertrude Elion, the Nobel-laureate chemist whose rational drug design pioneered life-saving medicines, the company has two assets in global development, including two ongoing global phase 2 programs in Cryptococcal meningitis and Early Antifungal Therapy. With top-line data readouts upcoming, the company is actively preparing for phase 3 readiness.

POSITION OVERVIEW

We are seeking an experienced and motivated Senior Director, Clinical Data Management to join our growing team. The Senior Director, Clinical Data Management is accountable for data management activities, data quality, and integrity for all Elion clinical programs. The incumbent will be a dynamic leader, with proven track record in driving strategic initiatives and fostering cross-functional collaboration to achieve company goals. Reporting to the Executive Vice President, Clinical Operations, the Sr. Director will identify and drive implementation of industry data management best practice solutions to ensure timely execution of data deliverables. The incumbent will bring expertise in implementing robust data governance frameworks, successful team management, and strong understanding of regulatory requirements.

KEY RESONSIBILITIES

• Clinical Data Management Strategy
• Drive development and adherence to clinical data management (CDM) vision, strategy, and operational excellence for global development programs.
• Lead the development and improvement of CDM standards, including SOPs, work instructions, electronic case report forms (eCRFs), eCRF completion guidelines, data transfer and handling agreements, data management and data review plans.
• Ensure all data management activities and processes follow Good Clinical Practice (GCP), relevant regulatory requirements, and SOPs and WIs
• Ensure compliance with Clinical Data Interchange Standards Consortium (CDISC) standards to ensure high data quality standards
• Proactively identify emerging challenges, operational risks, and technology needs, and execute mitigation strategies that ensure business continuity.
• Provide oversight of CDM vendors, ensuring contractually compliant and high-quality delivery of clinical data deliverables.
• Own the vendor selection process for CDM services, including RFI/RFP development, bid assessment, and bid-defense leadership in partnership with cross-functional partners.
• Define and track CDM-related KPIs and performance metrics, ensuring operational transparency, accountability, and data-driven decision-making.
• Provide CDM contributions to regulatory submissions, ensuring submission-ready datasets, documentation, and data reporting that meet global regulatory agency expectations.
• Manage the CDM budget, identifying opportunities to drive operational efficiencies, cost savings, that enhance data capabilities.
• Oversee preparation and management of internal and external audits and inspections, ensuring rapid resolution of findings and strengthening of quality systems.
• Advocate for functional involvement in key company and team deliverables ensuring CDM perspectives are integrated into key program initiatives.
• Optimize resource allocation across studies and programs, ensuring deployment of the right expertise and capacity to meet evolving business priorities and timelines.
• Lead and mentor CDM and clinical programming teams, providing expert guidance on data-related timelines, deliverables, standards, and cross-functional coordination.

• Cross-Functional Collaboration
• Partner with Nonclinical, Quality, and CMC teams to align data management activities with regulatory requirements.
• Communicate clearly across departments to support a shared understanding of clinical trial deliverables and timelines.
• Collaborate cross-functionally, uphold and role-model Elion’s Cultural Principles of Ingenuity, Collaboration, Open Communications, and Net Accountability (ICON).

QUALIFICATIONS

• Bachelor’s degree in a scientific discipline; PhD, MS/MA is preferred.
• Minimum of 12+ years of related experience and/or combination of experience and education/training.
• Demonstrated experience leading global data management activities and interface with cross functional leads (Biostatistics, Clinical Development & Operations, Medical/Pharmacovigilance, Regulatory, Quality).
• Experience participating in regulatory submissions and inspections.
• Experience in biotech/pharmaceutical industry.
• Proven track-record in clinical development, quality and regulatory standards (e.g., CDISC), policies relevant to Data Management, and risk-based approach of clinical data (e.g., GCP, ICH).
• Experience in Infectious Disease clinical trials is preferred.
• Experienced with Good Clinical Practices (GCP).
• Demonstrated success managing data management activities of Clinical Research Organizations
• Experience leading major change initiatives.
• Minimum of 10+ years of managing teams in a matrixed organization.
• Strong analytical and business communication skills.
• Ability to identify, author, maintain and train staff on key data management SOPs and work-practice guidelines.
• Boston or San Diego-based preferred.

WHAT WE OFFER

• A science-first culture where all functions are viewed as strategic partners contributing to the mission.
• A collaborative, mission-driven leadership team with deep domain expertise and a shared commitment to bringing better therapies to patients with serious infectious diseases.
• Competitive base salary benchmarked to biotech regulatory market rates in the Boston/Cambridge/San Diego life sciences ecosystems.
• Meaningful equity participation, structured to reflect the value creation opportunity ahead as Elion advances through clinical milestones and toward its next major financing event.
• Performance-based bonus tied to company and individual objectives.
• Comprehensive benefits including medical, dental, vision, health wellness reimbursement, unlimited PTO, and 401(k) with company matching.