Sr. Director, Clinical Operations Capabilities and Standards
Legend Biotech USA, Trenton, NJ, United States
Legend Biotech
seeks a
Sr. Director, Clinical Operations Capabilities and Standards
as part of the
Clinical Operations
team based in
Somerset, NJ .
Role Overview
Head of Clinical Operations Capabilities and Standards will be responsible for providing strategic leadership and oversight for foundational and centralized trial operations support towards cost‑effective scalability of the Clinical Operations department. The position will also serve as the company subject‑matter expert for clinical operations standards applied across the portfolio of Legend IND clinical trials.
Key Responsibilities
Oversee the development and strengthening of the following clinical operations capabilities and functions, each with leads and teams:
Clinical Trial Planning & Analytics
Responsible for end‑to‑end clinical trial feasibility activities, supporting protocol optimization, country and site selection, enrollment forecasting, and risk mitigation across clinical programs.
Provide data‑driven feasibility insights to enable informed decision‑making during early study planning and partner closely with Clinical Operations Leads, Clinical Development, cross‑functional stakeholders and external vendors.
Responsible for predictive trial performance modeling to enable proactive implementation of contingency plans.
Clinical Trial Operational Technologies
Owns strategic ownership, governance, and optimization of clinical trial operations systems, ensuring compliance, efficiency, and inspection‑readiness.
Business owner for core clinical systems (CTMS, eTMF, and related platforms), aligning with clinical operations needs, regulatory requirements, and development portfolio.
Guides technology to enable cost‑efficient trial budget builds, ongoing cost optimization, and risk‑management tools.
Vendor Alliance Management
Strategic and operational oversight of external clinical operations vendors and CRO partners, including vendor due diligence and qualification.
Interface between internal Clinical Operations Program Leads and external service providers, responsible for vendor governance, performance management, issue escalation, and continuous improvement.
Site Contracts & Payments
Creates and oversees a scalable operating model for site contracting, investigator payment operations, and improves operational control, process effectiveness, financial discipline, vendor performance consistency, and sponsor‑CRO‑site workflow alignment.
Sample & Imaging Management Operations
Oversees end‑to‑end sample and imaging across Legend pipeline studies, enhancing visibility, accountability, and coordination across sites, CROs, central labs, and imaging vendors.
Focuses on system‑level consistency and risk reduction, mitigating loss of patient data, accelerating data cleaning, and reducing site burden.
Business owner for clinical operations standards and practices, including SOPs and guidance documents.
Performs other duties as required.
Key Relationships
Works closely with all applicable internal cross‑functional leaders and teams as well as external vendors for clinical operations capability building and strengthening.
Requirements
Minimum degree: BA or BS in a scientific or health care discipline; advanced degree preferred.
12+ years of progressive experience in pharmaceutical or biotechnology clinical operations, with demonstrated leadership across global clinical development programs.
Extensive experience establishing, scaling, or transforming centralized Clinical Operations capabilities, including at least one of the following: Clinical Trial Planning & Analytics, Clinical Trial Operational Technologies, Vendor Alliance Management, Site Contracts & Investigator Payments, Sample & Imaging Management Operations.
Expertise in end‑to‑end clinical trial conduct, including early to late phase trials, strong understanding of protocol development, feasibility, start‑up, execution, and close‑out.
Strategic CRO and vendor oversight experience, including governance models, performance metrics, financial oversight, issue escalation, and continuous improvement.
Experience as a functional or enterprise‑level clinical operations subject‑matter expert, defining standards, operating models, and best practices across multiple studies.
Strong collaboration background with Quality, Regulatory, Clinical Development, Data Management, Biostatistics, Medical Writing, Pharmacovigilance, Translational/Bioanalytical, Medical Affairs, Procurement, Legal and IT functions.
Preferred experience in supporting regulatory authority interactions (e.g., FDA inspections) related to clinical operations processes, vendors, systems, or trial conduct.
Demonstrated success leading, developing, and retaining high‑performing teams, including functional leaders.
Willingness to travel (approximately 10%).
Deep knowledge of clinical trial operations frameworks, including ICH‑GCP, FDA, and global health authorities.
Strong capability in clinical operations operating model design, including centralization, standardization, governance, and scalability.
Leadership in clinical operations technology enablement, including ownership of systems, data quality oversight, technology‑enabled risk management, and inspection readiness.
Expertise in vendor and alliance management: governance structures, KPI frameworks, financial oversight, and performance optimization.
Understanding of clinical trial sample, imaging, and data flows, designing operational controls to reduce data risk and site burden.
Ability to translate portfolio‑level strategy into executable clinical operations capabilities, standards, and guidance.
Strategic and critical thinking skills with a data‑driven mindset to anticipate operational risks and mitigations.
Experience developing, authoring, and governing clinical operations SOPs, standards, and guidance.
Exceptional communication, presentation, and stakeholder influence skills, engaging senior leadership and cross‑functional teams.
High proficiency with Clinical Operations‑relevant technologies and tools such as MS Office (Excel, PowerPoint, Word) and enterprise clinical systems; ability to leverage analytics for decision‑making.
EEO Statement
It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state, or local laws or ordinances. Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company.
#J-18808-Ljbffr
seeks a
Sr. Director, Clinical Operations Capabilities and Standards
as part of the
Clinical Operations
team based in
Somerset, NJ .
Role Overview
Head of Clinical Operations Capabilities and Standards will be responsible for providing strategic leadership and oversight for foundational and centralized trial operations support towards cost‑effective scalability of the Clinical Operations department. The position will also serve as the company subject‑matter expert for clinical operations standards applied across the portfolio of Legend IND clinical trials.
Key Responsibilities
Oversee the development and strengthening of the following clinical operations capabilities and functions, each with leads and teams:
Clinical Trial Planning & Analytics
Responsible for end‑to‑end clinical trial feasibility activities, supporting protocol optimization, country and site selection, enrollment forecasting, and risk mitigation across clinical programs.
Provide data‑driven feasibility insights to enable informed decision‑making during early study planning and partner closely with Clinical Operations Leads, Clinical Development, cross‑functional stakeholders and external vendors.
Responsible for predictive trial performance modeling to enable proactive implementation of contingency plans.
Clinical Trial Operational Technologies
Owns strategic ownership, governance, and optimization of clinical trial operations systems, ensuring compliance, efficiency, and inspection‑readiness.
Business owner for core clinical systems (CTMS, eTMF, and related platforms), aligning with clinical operations needs, regulatory requirements, and development portfolio.
Guides technology to enable cost‑efficient trial budget builds, ongoing cost optimization, and risk‑management tools.
Vendor Alliance Management
Strategic and operational oversight of external clinical operations vendors and CRO partners, including vendor due diligence and qualification.
Interface between internal Clinical Operations Program Leads and external service providers, responsible for vendor governance, performance management, issue escalation, and continuous improvement.
Site Contracts & Payments
Creates and oversees a scalable operating model for site contracting, investigator payment operations, and improves operational control, process effectiveness, financial discipline, vendor performance consistency, and sponsor‑CRO‑site workflow alignment.
Sample & Imaging Management Operations
Oversees end‑to‑end sample and imaging across Legend pipeline studies, enhancing visibility, accountability, and coordination across sites, CROs, central labs, and imaging vendors.
Focuses on system‑level consistency and risk reduction, mitigating loss of patient data, accelerating data cleaning, and reducing site burden.
Business owner for clinical operations standards and practices, including SOPs and guidance documents.
Performs other duties as required.
Key Relationships
Works closely with all applicable internal cross‑functional leaders and teams as well as external vendors for clinical operations capability building and strengthening.
Requirements
Minimum degree: BA or BS in a scientific or health care discipline; advanced degree preferred.
12+ years of progressive experience in pharmaceutical or biotechnology clinical operations, with demonstrated leadership across global clinical development programs.
Extensive experience establishing, scaling, or transforming centralized Clinical Operations capabilities, including at least one of the following: Clinical Trial Planning & Analytics, Clinical Trial Operational Technologies, Vendor Alliance Management, Site Contracts & Investigator Payments, Sample & Imaging Management Operations.
Expertise in end‑to‑end clinical trial conduct, including early to late phase trials, strong understanding of protocol development, feasibility, start‑up, execution, and close‑out.
Strategic CRO and vendor oversight experience, including governance models, performance metrics, financial oversight, issue escalation, and continuous improvement.
Experience as a functional or enterprise‑level clinical operations subject‑matter expert, defining standards, operating models, and best practices across multiple studies.
Strong collaboration background with Quality, Regulatory, Clinical Development, Data Management, Biostatistics, Medical Writing, Pharmacovigilance, Translational/Bioanalytical, Medical Affairs, Procurement, Legal and IT functions.
Preferred experience in supporting regulatory authority interactions (e.g., FDA inspections) related to clinical operations processes, vendors, systems, or trial conduct.
Demonstrated success leading, developing, and retaining high‑performing teams, including functional leaders.
Willingness to travel (approximately 10%).
Deep knowledge of clinical trial operations frameworks, including ICH‑GCP, FDA, and global health authorities.
Strong capability in clinical operations operating model design, including centralization, standardization, governance, and scalability.
Leadership in clinical operations technology enablement, including ownership of systems, data quality oversight, technology‑enabled risk management, and inspection readiness.
Expertise in vendor and alliance management: governance structures, KPI frameworks, financial oversight, and performance optimization.
Understanding of clinical trial sample, imaging, and data flows, designing operational controls to reduce data risk and site burden.
Ability to translate portfolio‑level strategy into executable clinical operations capabilities, standards, and guidance.
Strategic and critical thinking skills with a data‑driven mindset to anticipate operational risks and mitigations.
Experience developing, authoring, and governing clinical operations SOPs, standards, and guidance.
Exceptional communication, presentation, and stakeholder influence skills, engaging senior leadership and cross‑functional teams.
High proficiency with Clinical Operations‑relevant technologies and tools such as MS Office (Excel, PowerPoint, Word) and enterprise clinical systems; ability to leverage analytics for decision‑making.
EEO Statement
It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state, or local laws or ordinances. Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company.
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