Director, Clinical Technical Operations

Otsuka Pharmaceutical Co., Ltd; Northern (KY); Hybrid; USD 186,000 - 279,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) match

Paid time off

Job summary

Otsuka Pharmaceutical Co., Ltd. seeks a Director, Clinical Technical Operations to lead the technology ecosystem powering global clinical trials. You will drive strategy, oversee CTMS/eTMF/EDC platforms, and ensure data governance, RBQM, and inspection readiness across programs.

You will partner with Clinical Operations and external vendors to optimize study planning, execution, and quality while enabling scalable, compliant operations and data-driven decisions.

Qualifications

• Required Bachelor’s degree in Life Sciences, Clinical Research, Nursing, Pharmacy, Public Health, Information Systems, or related discipline.
• Minimum 12+ years in pharmaceutical/biotech/CRO environments supporting clinical operations.
• Minimum 10+ years of leadership experience managing teams, programs, or cross-functional initiatives.
• Extensive experience with clinical trial technologies and digital platforms (CTMS, eTMF, EDC, IRT, eCOA/ePRO).
• Strong understanding of RBQM/RBM and data governance in a regulated environment.
• Experience overseeing CROs and external service providers in clinical development.

Responsibilities

• Lead Clinical Technology Strategy & Leadership to drive digital transformation and study execution.
• Oversee Clinical Systems & Platform governance, validation, and lifecycle management.
• Drive Data Governance, analytics, and enterprise data architecture for operational transparency.
• Partner with Clinical Operations to ensure compliant, efficient trial delivery across phases.
• Lead process optimization, automation, and technology-enabled quality improvements.
• Manage cross-functional teams and vendor relationships to align investments with program needs.
• Ensure inspection readiness, quality, and regulatory compliance across systems.

Skills

Leadership

Strategic thinking

Stakeholder mgmt

Data governance

Vendor mgmt

Cross-functional

Education

Bachelor's degree in Life Sciences/related

Advanced degree preferred (MS/MBA/MPH)

Tools

CTMS

eTMF

EDC

IRT

eCOA/ePRO

Job description

Job Summary

The Director, Clinical Technical Operations provides leadership and oversight for the technology ecosystem that supports global clinical trial programs. This role is responsible for executing the Clinical Management technology strategy, ensuring that clinical systems, digital processes, data governance frameworks, and technology-enabled capabilities effectively support the planning, execution, oversight, and inspection readiness of clinical trials. The Director serves as a key business partner across applicable internal business functions and external service providers. The role leads operational excellence, technology transformation, and data-driven decision-making through the implementation and optimization of clinical technologies, integrated platforms, automation solutions, and clinical operational data initiatives. In addition to technology leadership responsibilities, the role provides expertise and guidance in clinical trial operations to ensure technology investments effectively support study planning, execution, quality oversight, risk management, and successful delivery of clinical development programs. This individual leads a team of Clinical Technical Operations professionals and contributes to strategic vendor relationships, technology roadmaps, governance committees, and cross-functional initiatives to ensure compliant, scalable, and effective and scalable clinical operations capabilities.

Key Responsibilities

• Clinical Technology Strategy & Leadership

  Execute Clinical Technical Operations plans and priorities aligned with corporate and Clinical Management objectives. Contribute to development and execution of clinical technologies, digital innovation, system integrations, automation, and data management capabilities. Serve as a subject matter expert for and key partner on behalf of Clinical Management on emerging technologies, industry trends, and best practices associated with utilization of associated technologies. Lead implementation and optimization initiatives in support of digital transformation to improve study execution, operational efficiency, data quality, inspection readiness, and user experience. Participate in governance processes for clinical systems, technology investments, prioritization, and change management.

• Clinical Systems & Platform Oversight

  Provide strategic oversight for the implementation, optimization, validation, maintenance, and lifecycle management of clinical systems, including but not limited to: CTMS, eTMF, Master Data Management tools, digital trial technologies, study start-up systems, Clinical analytics and reporting platforms. Ensure seamless integration and interoperability across internal and external systems supporting clinical operations. Establish system governance standards, performance expectations, and continuous improvement frameworks. Partner with IT and business stakeholders to ensure systems remain scalable, secure, compliant, and fit for purpose.

• Data Governance, Architecture & Analytics

  Establish and oversee data governance frameworks supporting clinical operational data. Drive enterprise standards for data stewardship, ownership, quality, retention, security, and lifecycle management. Provide strategic oversight of clinical data flows, integrations, data mappings, and system architecture. Ensure documentation of data flow diagrams, system architecture, and business process maps to support operational transparency, compliance, and audit readiness. Champion the use of operational analytics, business intelligence, dashboards, and predictive metrics to support data-driven decision-making. Collaborate with Data Management, Biostatistics, IT, and other applicable stakeholders to advance integrated data strategies.

• Clinical Operations Excellence & Trial Execution

  Serve as a strategic partner to Clinical Operations leadership to ensure technology solutions support efficient and compliant study execution across all phases of clinical development. Maintain deep understanding of clinical trial conduct, including study start-up, enrollment, monitoring, issue management, data review, study closeout, and inspection readiness activities. Evaluate operational performance metrics and trial execution challenges to identify opportunities for technology-enabled improvements in study delivery. Ensure clinical systems and data strategies align with operational needs for site management, enrollment forecasting, protocol execution, monitoring effectiveness, risk management, and study timelines. Partner with Clinical Operations teams to implement and optimize risk-based quality management (RBQM) and risk-based monitoring (RBM) approaches. Support development and standardization of clinical operational processes, SOPs, work instructions, and best practices across global clinical programs. Facilitate proactive identification and mitigation of operational risks impacting study timelines, quality, budget, and patient safety associated with technology utilization. Collaborate with study teams to establish operational dashboards, KPIs, KRIs, and performance metrics supporting portfolio oversight and study health assessments. Drive operational inspection readiness through robust oversight of documentation, quality metrics, issue management, and compliance processes. Ensure technology platforms provide meaningful insights that support trial delivery, enrollment performance, site productivity, monitoring effectiveness, and resource planning.

• Process Optimization & Innovation

  Lead initiatives that enhance clinical trial execution through workflow automation, process simplification, and digital enablement. Identify opportunities to improve operational efficiency, reduce cycle times, and mitigate quality and compliance risks. Evaluate and implement technology enhancements that improve clinical operations. Establish key performance indicators and success metrics to assess technology effectiveness and business impact.

• Cross-Functional Leadership

  Partner with Clinical Management leadership and cross-functional stakeholders to align technology capabilities with development program needs. Lead cross-functional project teams supporting technology implementation, organizational change, and process transformation. Provide recommendations regarding technology investments, operating models, and resource allocation. Ensure successful implementation, adoption, and ongoing optimization of new technologies across the organization.

• Compliance, Quality & Inspection Readiness

  Ensure clinical technologies and associated processes comply with applicable global regulatory requirements and standards. Partner with Quality Assurance and Information Technology to maintain validated and compliant systems. Ensure readiness for internal audits, regulatory inspections, and vendor assessments. Lead investigation and remediation of technology-related quality issues, audit findings, and CAPAs.

• People Leadership

  Lead and develop a Clinical Technical Operations team. Provide strategic direction, coaching, mentoring, and succession planning for direct reports. Establish team goals, performance expectations, and professional development plans. Foster a culture of accountability, continuous improvement, innovation, collaboration, and patient focus. Support workforce planning and organizational capabilities to support current and future business needs.

• Performance Management & Reporting

  Define, monitor, and report key metrics related to system utilization, data quality, operational efficiency, user adoption, and technology ROI. Present operational performance, risks, and improvement opportunities to senior leadership and governance committees. Develop executive dashboards and reporting frameworks supporting portfolio-level oversight and decision-making.

Qualifications

• Required Bachelor's degree in Life Sciences, Clinical Research, Nursing, Pharmacy, Public Health, Information Systems, or related discipline.
• Minimum 12+ years of experience within pharmaceutical, biotechnology, or CRO environments supporting clinical operations.
• Minimum 10+ years of leadership experience managing teams, programs, or complex cross-functional initiatives.
• Extensive experience with clinical trial technologies and digital platforms, including CTMS, eTMF, EDC, IRT, eCOA/ePRO, and related systems.
• Demonstrated expertise in end-to-end clinical trial operations, including study start-up, site activation, enrollment management, monitoring oversight, study closeout, and inspection readiness.
• Strong understanding of Clinical Operations functional processes, metrics, and operational risk management methodologies.
• Experience utilizing clinical operational metrics, key risk indicators (KRIs), and performance dashboards to drive decision-making and oversight.
• Working knowledge of clinical development processes across Phase I–IV studies and global clinical trial execution models and regulations.
• Strong understanding of inspection readiness expectations and quality management principles.
• Demonstrated success leading technology implementation, digital transformation, and process improvement initiatives at an organizational level.
• Experience with system integration strategies, operational data governance, and enterprise architecture concepts.
• Demonstrated experience overseeing CROs, clinical vendors, and strategic service providers in a regulated clinical development environment.
• Proven ability to influence senior stakeholders and drive cross-functional alignment.
• Excellent leadership, communication, project management, and strategic planning skills.
• Proficiency in Microsoft Office applications and business intelligence/reporting tools.
• Willingness to travel as needed.
• Preferred Advanced degree (MS, MBA, MPH, or equivalent).
• Prior experience in Clinical Operations leadership, Study Management, Clinical Program Management, or Clinical Trial Management.
• Experience supporting hybrid and technology-enabled clinical trial models.
• Experience developing clinical operations performance frameworks and portfolio-level operational reporting.
• Experience supporting complex global clinical development programs.
• Experience with enterprise data governance, business intelligence, analytics platforms, and automation technologies.
• Experience leading organizational change management initiatives and large-scale technology deployments.
• Relevant certifications in project management, clinical research, information systems, or quality management.

Competencies

• Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
• Strategic Thinking & Problem Solving - Make decisions considering the long‑term impact to customers, patients, employees, and the business.
• Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
• Impactful Communication - Communicate with logic, clarity, and respect.
• Influence at all levels to achieve the best results for Otsuka.
• Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
• Empowered Development - Play an active role in professional development as a business imperative.

Salary

Minimum $186,489.00 - Maximum $278,875.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Application Deadline

This will be posted for a minimum of 5 business days.

Disclaimer

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting [e-mail].