Executive Director, Clinical Operations Capabilities and Standards

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting‑edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking an Executive Director, Clinical Operations Capabilities and Standards as part of the Clinical Operations team based in Somerset, NJ. Role Overview The Executive Director, 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. Among other responsibilities, this position will establish, oversee and grow Clinical Operations capability pillars that include Clinical Trial Planning and Analytics, Clinical Trial Operational Technologies, Clinical Trial Monitoring Standards, Vendor Alliance Management, Site Contracts & Payments, and Sample & Imaging Management Operations; including managing and developing staff within each pillar. This position will also serve as a strategic partner to the Clinical Operations team and broader leadership team, accountable for driving the design, standardization, and continuous evolution of core clinical operational capabilities across the clinical portfolio including enabling the centralization of clinical operational standards. Key Responsibilities Clinical Trial Planning & Analytics: Provide strategic oversight of end‑to‑end feasibility and trial planning, including protocol optimization, country and site selection, enrollment forecasting, and risk mitigation across clinical programs. Ensure data‑driven feasibility insights to enable informed decision‑making during early study planning. Partner closely with Clinical Operations Leads, Clinical Development, cross‑functional stakeholders and external vendors to ensure trials are designed and placed for successful execution. Establish predictive trial performance modeling to enable proactive implementation of contingency plans. Clinical Trial Operational Technologies: Oversee enterprise standards for clinical monitoring across all Legend IND portfolio of studies that will be applicable across global markets. Enabling consistency in monitoring approaches (risk‑based monitoring, central monitoring, hybrid models) for both in‑house monitoring and/our outsourced monitoring operating models. Oversee development and ownership of monitoring‑related SOPs and/or oversee adoption of consistent CRO SOPs for monitoring) Vendor Alliance Management: Provides strategic and operational oversight of external clinical operations vendors and CRO partners supporting clinical trials, including overseeing vendor due diligence for vendor qualification. Ensures vendors deliver high‑quality services across the portfolio in compliance with GxP and contractual expectations, while enabling efficient study execution across one or more clinical programs. Establish and maintain robust vendor governance, performance management via objective metrics, issue escalation, and continuous improvement. Serves as escalation point for critical vendor‑related risks and issues. Site contracts and Payments Oversee the development of scalable and effective operating model for site contracting visibility, investigator payment operations, serving as a central point of accountability for improving operational control, process effectiveness, financial discipline, vendor performance consistency, and sponsor‑CRO‑site workflow alignment. Sample and Imaging Management Operations Provides leadership to enable end‑to‑end sample and imaging oversight across Legend pipeline studies; towards strengthening visibility, accountability, and coordination across sites, CROs, central labs, specialty labs, imaging vendors. Oversees system‑level consistency and risk reduction, mitigating against loss of patient data, acceleration of data cleaning and reducing site burden for participation in clinical trials. Key Relationships Acts as key member of the Clinical Operations leadership team, supporting the VP of Clinical Operations in driving organizational priorities and strategic initiatives. Lead business owner for clinical operations standards and practices, including functional owner for clinical operational related SOPs and guidance documents. The Executive Director, Clinical Operations Capabilities and Standards 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 requirements of a bachelor’s degree (BA, BS) in scientific or health care discipline. Advance Degree Preferred. 15+ years of progressive experience in pharmaceutical or biotechnology clinical operations, with demonstrated leadership responsibility across global clinical development programs. Significant experience in establishing, scaling, or transforming centralized Clinical Operations capabilities, including one or more of the following: Clinical Trial Planning & Analytics / Feasibility Clinical Trial Operational Technologies (e.g., CTMS, eTMF, analytics platforms) Vendor Alliance Management Site Contracts and Investigator Payments Sample and Imaging Management Operations Proven expertise in end‑to‑end clinical trial conduct, including early‑phase through late‑phase trials, with strong understanding of protocol development, feasibility, start‑up, execution, and close‑out. Demonstrated strategic CRO and vendor oversight experience, including governance models, performance metrics, financial oversight, issue escalation, and continuous improvement. Experience acting as a functional or enterprise‑level clinical operations subject‑matter expert, defining standards, operating models, and best practices applied across multiple studies or programs. Strong background collaborating with Quality, Regulatory, Clinical Development, Data Management, Biostatistics, Medical Writing, Pharmacovigilance, Translational/Bioanalytical, Medical Affairs, Procurement, Legal and IT functions in a matrixed global environment. Experience participating in and/or supporting regulatory authority interactions (e.g., FDA inspections) related to clinical operations processes, vendors, systems, or trial conduct is strongly preferred. Demonstrated success leading, developing, and retaining high‑performing teams, including functional leaders. Willingness to travel as required (approximately 10%). Deep knowledge of clinical trial operations frameworks, including industry best practices and regulatory expectations (ICH‑GCP, FDA, and global health authorities). Strong capability in clinical operations operating model design, including centralization, standardization, governance, and scalability. Demonstrated leadership in clinical operations technology enablement, including business ownership of systems (e.g., CTMS, eTMF), data quality oversight, technology‑enabled risk management, and inspection readiness. Expertise in vendor and alliance management, including development of governance structures, KPI frameworks, financial oversight, and performance optimization. Understanding of clinical trial sample, imaging, and data flows, with ability to design operational controls that reduce patient data risk, site burden, and cycle times. Ability to translate portfolio‑level strategy into executable clinical operations capabilities, standards, and guidance. Proven strategic and critical thinking skills, with a data‑driven mindset and ability to anticipate operational risks and mitigation strategies. Strong experience developing, authoring, and governing clinical operations SOPs, standards, and guidance documents. Exceptional communication, presentation, and stakeholder influence skills, with the ability to engage senior leadership and cross‑functional teams. High proficiency with clinical operations‑relevant technologies and tools, including MS Office (Excel, PowerPoint, Word) and enterprise clinical systems; ability to leverage analytics for operational decision‑making.

• Li-AS1
• Li-Hybrid

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws. Other Types of Pay: Performance‑based bonus and/or equity is available to employees in eligible roles. Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short‑and‑long‑term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well‑being initiatives, and peer‑to‑peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. Pay Range (Base Pay):

$256,073 — $336,097 USD

Please note: These benefits are offered exclusively to permanent full‑time employees. Contractors are not eligible for benefits through Legend Biotech. Work Authorization & Employment Eligibility Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E‑Verify program. If you are selected for employment, you will be required to complete the Form I‑9 process, and your employment eligibility will be verified through E‑Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates. 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. For information related to our privacy notice, please review: Legend Biotech Privacy Notice. #J-18808-Ljbffr Legendcareers