Executive Director, Data Management

Ray Therapeutics, Inc.; Berkeley (CA); Híbrido; USD 315.000 - 375.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Comprehensive benefits package

Hybrid work schedule

Descripción de la vacante

Ray Therapeutics seeks an Executive Director, Data Management in Berkeley, hybrid, to lead global clinical data-management strategy across its portfolio. You will build a scalable, inspection-ready function delivering high-quality, timely data for regulatory submissions and decision-making.

You will partner with Clinical Operations, Biostatistics, Regulatory Affairs, Quality, and IT, guiding start-up through archival, and managing vendor networks to ensure data integrity and timely insights.

Formación

• Bachelor’s degree in life sciences, computer science, information systems, biostatistics, or related; advanced degree preferred.
• Typically 12+ years of progressive clinical data-management experience with leadership responsibility.
• Experience leading data management across global clinical programs from early development through pivotal studies and regulatory submissions.

Responsabilidades

• Define and lead the clinical data-management vision, operating model, roadmap, and resourcing strategy across the portfolio.
• Build and lead a high-performing internal team and network of contract resources.
• Provide data-management leadership from protocol development through database lock, regulatory submission, and archival.
• Oversee development and maintenance of data-management plans, CRFs, edit-check specs, data-transfer agreements, reconciliation plans, coding conventions, and database lock plans.
• Establish and govern clinical data standards, including CDISC-aligned practices, controlled terminology, metadata, and reusable libraries.
• Ensure integration and traceability of data from EDC systems, imaging platforms, central labs, safety databases, PROs, devices, and external sources.
• Drive risk-based data review and data-cleaning strategies for timely issue resolution.
• Define and monitor quality, cycle-time, and vendor-performance metrics; identify risks and corrective actions.
• Select, qualify, and oversee data-management vendors and platforms with scope, budget, timelines, and inspection readiness.
• Partner with Biostatistics to ensure clean, analysis-ready datasets and coordinated database locks.
• Author and maintain data-management SOPs, WIs, templates, training, and QA processes.
• Represent Data Management on cross-functional teams, governance forums, regulatory interactions, audits, and inspections.
• Contribute to regulatory submission planning and data traceability responses.

Conocimientos

Leadership

Data management

CDISC standards

Regulatory submissions

Ophthalmology knowledge

Team building

Educación

Bachelor’s degree in life sciences or related field

Advanced degree preferred

Herramientas

EDC platforms

Data review tools

Medical coding

Data integration

Database validation

Database lock

Descripción del empleo

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Executive Director, Data Management

Full Time Management Berkeley, CA, US

6 days ago Requisition ID: 1019

Salary Range: $315,000.00 To $375,000.00 Annually

About Ray Therapeutics

Ray Therapeutics mission is to restore vision to people with retinal degenerations. RayTx is using a novel bioengineered optogenetic protein optimized for human vision delivered by AAV to restore visual function in a mutation agnostic approach and without the need for light enhancing eyewear. The company is developing its lead candidate in retinitis pigmentosa, a degenerative retinal disease with significant unmet medical need as well as a pipeline to treat both rare and large market indications.

Executive Director of Data Management, Berkeley, CA, Hybrid

The Executive Director of Data Management is a senior clinical-development leader responsible for establishing and executing Ray Therapeutics’ global clinical data-management strategy across its portfolio. This individual will build and lead a scalable, inspection-ready data-management function that delivers high-quality, timely, and reliable clinical data to support decision-making, regulatory submissions, and the advancement of innovative optogenetic therapies for retinal degenerative diseases.

The Executive Director will provide strategic and operational leadership across study start-up, conduct, database lock, submission, and archival. The role will partner closely with Clinical Operations, Clinical Science, Biostatistics, Statistical Programming, Regulatory Affairs, Pharmacovigilance, Medical Affairs, Quality, Information Technology, and external service providers to ensure that data-management processes, systems, standards, and deliverables meet program needs, applicable regulations, and industry best practices.

Formula for Success: Combining strategic leadership, deep clinical data-management expertise, and hands-on execution to build a scalable function and deliver submission-ready clinical data; you will:

• Define and lead the clinical data-management vision, operating model, roadmap, and resourcing strategy across the portfolio
• Build, develop, and lead a high-performing internal team and fit-for-purpose network of contract resources and service providers
• Provide data-management leadership from protocol development and study start-up through database lock, regulatory submission, and archival
• Oversee development and maintenance of data-management plans, electronic case report forms, edit-check specifications, data-transfer agreements, reconciliation plans, coding conventions, and database lock plans
• Establish and govern clinical data standards, including CDISC-aligned practices, controlled terminology, metadata, and reusable libraries
• Ensure effective integration, reconciliation, and traceability of data from electronic data-capture systems, imaging platforms, central laboratories, safety databases, patient-reported outcomes, devices, and other external sources
• Drive risk-based data review and data-cleaning strategies that support timely identification and resolution of critical data issues
• Define and monitor quality, cycle-time, and vendor-performance metrics; proactively identify risks, root causes, and corrective actions
• Select, qualify, and oversee data-management vendors and technology platforms, including scope, budget, timelines, performance, and inspection readiness
• Partner with Biostatistics and Statistical Programming to ensure clean, complete, analysis-ready datasets and coordinated database locks
• Author and maintain data-management standard operating procedures, work instructions, templates, training, and quality-control processes
• Represent Data Management on cross-functional development teams, governance forums, regulatory interactions, audits, and inspections
• Contribute to regulatory submission planning and delivery, including data traceability, documentation, and responses to health-authority questions
• Develop functional budgets, resource forecasts, and long-range capability plans aligned with portfolio priorities
• Promote a culture of accountability, collaboration, continuous improvement, data integrity, and patient focus

Your Qualifications include:

• Bachelor’s degree in life sciences, computer science, information systems, biostatistics, or a related discipline required; advanced degree preferred
• Typically 12 or more years of progressive clinical data-management experience in biotechnology, pharmaceutical, or contract research organizations, including significant leadership responsibility
• Demonstrated experience leading data management across global clinical programs from early development through pivotal studies and regulatory submissions
• Proven ability to build or scale a clinical data-management function, organization, systems, standards, and vendor model in a growing company
• Direct experience with electronic data-capture platforms, clinical data review tools, medical coding, external data integration, database validation, and database lock
• Strong knowledge of CDISC standards and regulatory expectations for clinical data, including applicable FDA and global requirements, ICH-GCP, and data-integrity principles
• Experience supporting regulatory submissions, health-authority interactions, audits, and inspections
• Demonstrated success selecting and managing contract research organizations, functional service providers, and technology vendors against quality, timeline, and budget expectations
• Strong understanding of clinical-trial design, operational data flows, safety and laboratory reconciliations, statistical deliverables, and cross-functional dependencies
• Experience in ophthalmology, retinal disease, gene therapy, AAV therapeutics, optogenetics, or other advanced therapeutic modalities is highly desirable
• Strategic and analytical mindset with the ability to translate portfolio needs into pragmatic, scalable processes and systems
• Excellent leadership, influencing, communication, and presentation skills, with the ability to work effectively across functions and organizational levels
• Demonstrated ability to attract, develop, and retain talent and to lead through growth and change
• Ability to manage multiple priorities in a fast-paced, resource-conscious biotechnology environment
• Ability to travel approximately 20%
• Ability to work in our Berkeley office 3 days per week

Compensation Range and Benefits: For this role, the anticipated base salary range will be $315,000 - $375,000, determined based on the candidate's professional experience level. The final salary offered for this position may take into account a number of factors including, but not limited to, skills, education, and experience. Ray Therapeutics also offers an annual performance-based bonus and a comprehensive benefits package.

At Ray Therapeutics, we celebrate diversity and are committed to creating an inclusive environment for all employees; providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.

All employment is decided on the basis of qualifications, merit, and business need.

Search Firm Representatives Please Read Carefully

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