Director, Clinical Technical Operations

Job not on LinkedIn

🔥 1 hour ago

🇺🇸 United States – Remote

💵 $186.5k - $278.9k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• Execute Clinical Technical Operations plans and priorities aligned with corporate and Clinical Management objectives • Contribute to clinical technologies, digital innovation, system integrations, automation, and data management capabilities • Serve as a subject matter expert and key partner on emerging technologies, industry trends, and best practices • Lead implementation and optimization initiatives 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 • Provide strategic oversight for implementation, optimization, validation, maintenance, and lifecycle management of clinical systems including CTMS, eTMF, Master Data Management tools, digital trial technologies, study start-up systems, and clinical analytics/reporting platforms • Ensure integration and interoperability across internal and external systems supporting clinical operations • Establish system governance standards, performance expectations, and continuous improvement frameworks • Establish and oversee clinical operational data governance frameworks • Drive standards for data stewardship, ownership, quality, retention, security, and lifecycle management • Oversee clinical data flows, integrations, data mappings, and system architecture • Ensure documentation of data flow diagrams, system architecture, and business process maps • Champion operational analytics, business intelligence, dashboards, and predictive metrics • Partner with Clinical Operations leadership to support efficient and compliant study execution across all phases of clinical development • Evaluate trial execution challenges and performance metrics to identify technology-enabled improvements • Implement and optimize risk-based quality management and risk-based monitoring approaches • Support standardization of clinical operational processes, SOPs, work instructions, and best practices • Identify and mitigate operational risks affecting timelines, quality, budget, and patient safety • Establish dashboards, KPIs, KRIs, and performance metrics for portfolio oversight and study health assessments • Drive operational inspection readiness through documentation, quality metrics, issue management, and compliance processes • Lead workflow automation, process simplification, and digital enablement initiatives • Lead cross-functional project teams for technology implementation, organizational change, and process transformation • Recommend technology investments, operating models, and resource allocation • Ensure implementation, adoption, and optimization of new technologies • Ensure compliance with 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 • Define, monitor, and report 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 • Lead and develop the Clinical Technical Operations team through direction, coaching, mentoring, succession planning, goal setting, and professional development • Support workforce planning and organizational capabilities

🎯 Requirements

• 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 • 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) • Preferred: prior experience in Clinical Operations leadership, Study Management, Clinical Program Management, or Clinical Trial Management • Preferred: experience supporting hybrid and technology-enabled clinical trial models • Preferred: experience developing clinical operations performance frameworks and portfolio-level operational reporting • Preferred: experience supporting complex global clinical development programs • Preferred: experience with enterprise data governance, business intelligence, analytics platforms, and automation technologies • Preferred: experience leading organizational change management initiatives and large-scale technology deployments • Preferred: relevant certifications in project management, clinical research, information systems, or quality management

🏖️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage • Company-provided basic life insurance • Accidental death and dismemberment insurance • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Other company-provided benefits • Incentive opportunity