Sr. Director, Clinical Operations Capabilities and Standards

Role Overview Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we develop 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 worldwide, 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, a pharmaceutical company of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). Our strategic partnership combines the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Sr. Director, Clinical Operations Capabilities and Standards Position located in Somerset, NJ as part of the Clinical Operations team. Key Responsibilities Clinical Trial Planning & Analytics Accountable for end‑to‑end clinical trial feasibility activities, supporting protocol optimization, country and site selection, enrollment forecasting, and risk mitigation across clinical programs. Provides data‑driven feasibility insights to enable informed decision‑making during early study planning and partners closely with Clinical Operations Leads, Clinical Development, cross‑functional stakeholders and external vendors to ensure trials are designed and placed for successful execution. Responsible for predictive trial performance modeling to enable proactive implementation of contingency plans. Clinical Trial Operational Technologies Strategic ownership, governance, and optimization of clinical trial operations systems that enable compliant, efficient, and inspection‑ready execution of clinical trials. Business owner for core clinical systems (e.g., CTMS, eTMF, and related platforms), ensuring alignment with clinical operations needs, regulatory requirements, and the company’s development portfolio. Partners closely with Clinical Operations Leads, Quality, Regulatory, Data Management, IT, and CROs/external vendors. Focus on leveraging technology to enable cost‑efficient trial budget builds and ongoing cost optimization during study execution, and enable tools for targeted clinical operations risk management and technology‑enabled eTMF oversight. Vendor Alliance Management Strategic and operational oversight of external clinical operations vendors and CRO partners supporting clinical trials, including coordination of vendor due diligence for vendor qualification. Ensures vendors deliver high‑quality services in compliance with GxP and contractual expectations, enabling efficient study execution across one or more clinical programs. Primary interface between internal Clinical Operations Program Leads and external service providers, with accountability for vendor governance, performance management via objective metrics, issue escalation, and continuous improvement. Site Contracts & Payments Creates and oversees a 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 & Imaging Management Operations End‑to‑end sample and imaging oversight across Legend pipeline studies, strengthening visibility, accountability, and coordination across sites, CROs, central labs, specialty labs, and imaging vendors. Focuses on system‑level consistency and risk reduction, mitigating against loss of patient data, enabling acceleration of data cleaning and reducing site burden for participation in clinical trials. Lead business owner for clinical operations standards and practices, including functional owner for clinical operational related 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 the clinical operations capability building and strengthening. Requirements Minimum degree requirements of a bachelor’s degree (BA, 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 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, startup, 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. Benefits and Paid Time Off Medical, dental, and vision insurance; a 401(k) retirement plan with a company match that vests fully on day one. Eight (8) weeks of paid parental leave after three (3) months of employment. Paid time off policy includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits: flexible spending and health savings accounts, life and AD&D insurance, short‑ and long‑term disability coverage, legal assistance, 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 commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. Pay Range (Base Pay) $222,672 – $292,258 USD. 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. Note These benefits are offered exclusively to permanent full‑time employees. Contractors are not eligible for benefits through Legend Biotech. 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 BioSpace