CHRISTINE EBY
Union
Summary
Strategic clinical development and operations leader with extensive experience directing global clinical programs across rare diseases, gene therapy, neurology, pediatrics, and complex biologics. Proven track record of shaping clinical strategy, leading cross-functional teams, and delivering high-impact programs from early engagement through global execution. Recognized for building high-performing teams, strengthening operational frameworks, and partnering closely with scientific, regulatory, and executive stakeholders to advance innovative therapies. Brings deep expertise in complex trial execution, unique operational demands of cell and gene therapy, passion and patient-centric leadership—grounded in both professional experience and personal connection to Type 1 diabetes.
Overview
22
22
years of professional experience
Work History
Director, Clinical Project Management
CTI Clinical Trial & Consulting Services
01.2025 - Current
- Senior leader overseeing global clinical operations across gene therapy, rare disease, neurology, endocrine and pediatrics.
- Responsible for strategic planning, operational execution, and cross-functional alignment for complex, high-visibility programs.
- Lead all strategic and tactical operational aspects of global programs, including oversight of CROs, vendors, and cross-functional partners.
- Serve as senior operational thought partner to executive leadership and sponsors, contributing to clinical development strategy, risk planning, and long-range forecasting.
- Drive lean, efficient execution through scenario planning, resource modeling, and budget governance.
- Perform hands-on Clinical Project Manager and CTM-level tasks when needed to maintain momentum and support team capacity—mirroring Sana’s “scrappy” culture.
- Provided strategic leadership for global clinical programs developing first-in-class and next-generation therapies, including gene therapies, cell-based treatments, and other innovative modalities.
- Directed end-to-end delivery of early- and late-phase trials, balancing scientific innovation with operational practicality to support rapid, high-quality program advancement.
- Build, mentor, and elevate high-performing clinical operations teams; coach CPMs and Study Team Leaders to expand capability and readiness for increased responsibility.
- Strengthen operational frameworks, implement process improvements, and elevate organizational capability in advanced therapeutics and rare disease execution.
- Direct resource planning, budget oversight, and operational governance across a portfolio of global trials.
- Represent clinical operations at executive-level meetings, providing clear communication of risks, timelines, budgets, and strategic recommendations.
- Led strategic oversight of CRO partners, niche laboratories, and specialized vendors critical to novel therapeutic platforms, ensuring alignment with scientific and operational objectives.
- Negotiated contracts, budgets, and governance frameworks tailored to small biotech clients, maximizing value while maintaining high performance expectations.
Director, Clinical Project Management & Therapeutic Strategy Lead, Rare Disease
CTI Clinical Trial & Consulting Services
01.2022 - 01.2025
- Dual strategic and operational leadership role supporting CTI’s Rare Disease Center of Excellence.
- Led therapeutic strategy development for rare disease programs, shaping clinical direction, evidence-generation plans, and cross-functional decision-making to accelerate portfolio advancement.
- Provided expert guidance on rare disease landscape, clinical pathways, and unmet needs to inform program design and organizational prioritization.
- Provided therapeutic and operational leadership for early engagement, protocol design, and development strategy across gene therapy and rare disease programs.
- Led scenario planning, high-level forecasting, and global feasibility assessments to inform TPPs and development plans.
- Built strong relationships with KOLs, advocacy groups, and global investigators to support patient access and endpoint strategy.
- Championed innovation and smart risk-taking to improve trial design, patient experience, and operational efficiency.
- Applied deep understanding of rare disease communities, registries, and natural history datasets to guide trial design and feasibility assessments.
- Championed patient-centric approaches, integrating caregiver insights, burden-of-disease factors, and quality-of-life considerations into development plans.
- Evaluated competitive intelligence and evolving scientific data to continuously refine therapeutic strategy and maintain competitive positioning.
- Ensured operational feasibility and patient-centric design when dealing with small, geographically dispersed, or fragile patient populations.
Assistant Director, Clinical Project Management
CTI Clinical Trial & Consulting Services
01.2020 - 01.2022
- Oversaw global trials across multiple therapeutic areas, ensuring operational excellence, regulatory compliance, and milestone delivery.
- Led cross-functional teams and served as senior escalation point for operational challenges.
- Strengthened client relationships and contributed to organizational process improvements and staff development.
- Provided leadership, coaching, and operational direction to Clinical Project Managers, fostering team growth, accountability, and operational excellence.
- Presented program updates, risk profiles, and strategic recommendations to senior leadership, enabling clear and data-driven decision-making.
Clinical Project Manager
CTI Clinical Trial & Consulting Services
01.2014 - 01.2020
- Managed global clinical trials from start-up through close-out, including gene therapy, metabolic disorders, neurology, and pediatrics.
- Oversaw site management, vendor oversight, TMF quality, budget adherence, and operational delivery.
- Served as primary client contact and global trial lead for complex programs.
- Identified development risks and created mitigation strategies to ensure program timelines and deliverables remained on track.
Pediatric Audiologist / Operations Coordinator, Cochlear Implant Program/ Aural Rehabilitation Therapist
Cincinnati Children’s Hospital Medical Center
Cincinnati
01.2005 - 01.2013
- Analyzed age-appropriate audiologic, social, and educational needs for each patient to create specialized treatment plans (to include digital hearing aids, operations, and at-home therapy).
- Educated families to know key milestones for listening / language development, goal setting, and creation of home aural rehabilitation plans for children as well as adults unable to attend clinic therapy.
- Performed diagnostic pediatric hearing evaluations; testing included visual reinforced audiometry, behavioral observations, and play audiometry techniques, as well as performed comprehensive Auditory Brainstem Response testing, Otoacoustic Emission testing, and Acoustic Reflexes.
- Prescribed digital hearing aids and Cochlear Implants.
- Competency to program and/or MAP several hearing aid and cochlear implant manufacturers.
- Conducted electroacoustic analysis and real-ear measurements to provide appropriate amplification and/or stimulation.
- Conducted evoked potential evaluations for identification of neurological disorders; included evoked potential testing in operating room or performed on in-patients.
- Performed Aural Rehabilitation evaluations and therapy; provided families with age-appropriate milestones regarding listening and language development and developed individualized goals and recommendations for children with hearing aids and CIs.
- Participated in Individualized Education Program (IEP) meetings; served as consultant to various school districts.
- Precepted audiology graduate student externships and clinical practicum.
- Assisted in various research projects in conjunction with otolaryngology. Developed and participated in presentations to professionals in community, parents of hearing-impaired children, and staff at CCHMC.
Audiology: Leadership Education in Neurodevelopmental and Related Disabilities (LEND) Trainee
Cincinnati Children’s Hospital Medical Center
Cincinnati
01.2004 - 01.2005
- Performed audiologic evaluations and central auditory processing disorder evaluations on children with variety of disabilities; this was interdisciplinary arena where all children were assessed by several professionals to determine best treatment; collaborating professionals included developmental pediatricians, otolaryngologists, speech / language pathologists, psychologists, and social workers.
- In addition to audiologic diagnostics and treatment, traineeship included coursework, community outreach / presentations, family mentoring, and research regarding children with neurodevelopmental and related disabilities and rare diseases.
Education
Doctor of Audiology (AuD) - Audiology
University of Cincinnati
Master of Arts - Communication Sciences & Disorders
University of Cincinnati
Bachelor of Arts - Communication Sciences and Disorders
The Ohio State University
Skills
- Global clinical operations leadership
- Gene and cell therapy execution
- Rare disease and metabolic disorders
- Clinical development strategy
- Cross-functional governance
- Study start-up and execution
- Vendor and CRO management
- Budgeting and resource allocation
- Risk management and planning
- Team building and coaching
- Regulatory compliance (FDA, EMA)
- Patient-centric operational design
- Stakeholder engagement
Therapeutic Area Expertise
- Gene Therapy
- Cell Therapy
- Rare Disease
- Endocrinology
- Type 1 Diabetes (personal and professional insight)
- Pediatrics
- Neurology
- Neurodegenerative Disorders
- Inborn Errors of Metabolism
- Autoimmune Disease
- Lysosomal Storage Disorders
- Neurodevelopmental Disabilities
- Audiology
Certifications And Licensure
- Licensed Audiologist, Ohio Board of Speech Language and Hearing
- American Sign Language & Deaf Studies Certification
Core Capabilities
- Global Clinical Operations Leadership
- Gene Therapy & Cell Therapy Execution
- Rare Disease & Endocrine/Metabolic Disorders
- Clinical Development Strategy & Scenario Planning
- Cross-Functional Governance & Executive-Level Influence
- Study Start-Up & “Scrappy” Hands-On Execution
- Vendor & CRO Oversight
- Budgeting, Forecasting & Resource Allocation
- Risk Management & Long-Range Planning
- Team Building, Coaching & Organizational Development
- Regulatory Alignment (FDA, EMA, ICH/GCP)
- Patient-Centric Operational Design
- Executive-Level Sponsor & Stakeholder Engagement
Timeline
Director, Clinical Project Management
CTI Clinical Trial & Consulting Services
01.2025 - Current
Director, Clinical Project Management & Therapeutic Strategy Lead, Rare Disease
CTI Clinical Trial & Consulting Services
01.2022 - 01.2025
Assistant Director, Clinical Project Management
CTI Clinical Trial & Consulting Services
01.2020 - 01.2022
Clinical Project Manager
CTI Clinical Trial & Consulting Services
01.2014 - 01.2020
Pediatric Audiologist / Operations Coordinator, Cochlear Implant Program/ Aural Rehabilitation Therapist
Cincinnati Children’s Hospital Medical Center
01.2005 - 01.2013
Audiology: Leadership Education in Neurodevelopmental and Related Disabilities (LEND) Trainee
Cincinnati Children’s Hospital Medical Center
01.2004 - 01.2005
Doctor of Audiology (AuD) - Audiology
University of Cincinnati
Master of Arts - Communication Sciences & Disorders
University of Cincinnati
Bachelor of Arts - Communication Sciences and Disorders
The Ohio State University