Description

Legend Biotech is seeking a Senior Manager, Evidence Generation Operations as part of the Medical Affairs team based Remotely.

Role Overview

The Senior Manager, Medical Affairs, Evidence Generation Operations will be a key contributor focused on execution of evidence generation activities within Legend Biotech's US Medical Affairs organization. In this role, you will ensure that clinical research and evidence generation activities - including observational RWE studies, Investigator-Initiated Studies (IIS), and collaborative studies - are executed efficiently, on time, and in full compliance with all applicable regulations and company policies. This position plays a critical role in advancing Legend's cutting-edge cell therapy for multiple myeloma and our growing oncology pipeline. By delivering high-quality real-world data and insights, you will inform medical strategy and help improve patient outcomes.

As Senior Manager, Evidence Generation Operations, you will work under the strategic guidance of the Associate Scientific Director, RWE Generation, focusing on hands-on trial execution. You will collaborate cross-functionally with colleagues in Medical Affairs, Clinical Operations, Regulatory, Data Management, Biostatistics, Pharmacovigilance, Compliance, and external partners to drive seamless study implementation and results dissemination. The ideal candidate brings a growth mindset-both professionally and organizationally-and is comfortable adapting to shifting priorities while maintaining high-quality execution.

Key Responsibilities

• Evidence Generation Project Management: Provide operational management and coordination for a broad range of Medical Affairs-led evidence generation projects (including real-world evidence studies, investigator-initiated studies, and other observational research). Ensure these projects are executed in alignment with Medical Affairs objectives, delivered on time, and fully compliant with regulations and company policies.
• Site & Vendor Management: Oversee CROs, academic collaborators, and vendors to ensure quality deliverables and timeline adherence. Anticipate and address risks, remove operational barriers, and keep studies on track.
• Budget & Resource Management: Manage budgets and resources for evidence generation activities, tracking spend and forecasting needs to support timely decisions. Partner with Finance and Procurement to enable contracting, payments, and policy-compliant execution.
• Cross-Functional Coordination: Serve as a central coordinator across internal teams and external partners, ensuring clear communication, timely issue resolution, and alignment on study plans (Clinical Development, Regulatory, Drug Safety/Pharmacovigilance, Legal, Compliance, and co-development partners).
• Regulatory & Compliance: Ensure all evidence generation activities comply with relevant regulatory guidelines (e.g., FDA, EMA) and internal standards. Always keep studies audit-ready by maintaining thorough documentation.
• Data Quality and Reporting: Ensure high data quality and effective reporting for all evidence generation projects. Collaborate closely with Biostatistics and Data Management to align on data and reporting expectations, facilitate timely data reviews, and coordinate delivery of study outputs (e.g., reports, conference abstracts, publications).
• Process Improvement: Drive continuous improvement of evidence generation operations by identifying gaps, implementing practical solutions, and standardizing best practices (e.g., intake/review, tracking, templates, and tools).
• Under the strategic guidance of the Associate Scientific Director, you will drive day-to-day execution and coordination of evidence generation activities by maintaining project plans, timelines, milestones, and deliverables to ensure on-time, compliant, high-quality study execution. You will identify risks and operational issues, recommend solutions, and escalate items requiring strategic direction, scope changes, or additional budget/contract commitments for review and approval.

Requirements

• Bachelor's degree in life sciences, health sciences, or a related field (advanced degree such as PharmD, PhD, MPH, or MS in a scientific discipline preferred).
• Minimum 3 years of experience in clinical research, clinical trial operations, or medical affairs, including a track record of managing relevant studies.
• Oncology (hematology/oncology) or immunology experience is strongly preferred. Experience with clinical trials or research in cellular therapies (CAR-T trials) is highly desirable.
• Proven ability to manage complex projects and cross-functional study teams, including budget and timeline oversight. Experience supporting or coordinating Investigator-Initiated Studies (IIS) or other collaborative research projects is a plus. Adept at identifying and addressing operational challenges in trial execution.
• Prior experience managing external research partners, such as CROs, academic research collaborators, or alliance partners, in the execution of clinical trials or RWE projects. Ability to negotiate and manage study contracts, budgets, and vendor performance.
• Experience implementing compliance procedures and quality management in clinical research. Comfortable working within established SOPs and contributing to audits/inspections readiness for Medical Affairs-led studies.
• Strong understanding of clinical research methodologies, protocol development, and data management related to RWE/observational studies. Familiarity with GCP, ICH guidelines, FDA/EMA regulations, and compliance requirements for post-marketing research and IIS. Familiarity with clinical trial software and collaboration tools (e.g., electronic data capture systems, clinical trial management systems, SharePoint, investigator portals for IIS) is a plus.
• Experience implementing compliance procedures and quality management in clinical research. Comfortable working within established SOPs and contributing to audits/inspections readiness for Medical Affairs-led studies.
• Demonstrated proficiency with the most current computer operating systems, Microsoft Office 2013 (particularly Outlook, Word, Excel, and PowerPoint), SharePoint, Adobe Acrobat Professional, Concur, Veeva and other PC-based applications. Familiar with AI based platforms including Copilot.
• Excellent written and verbal communication skills, with an ability to translate complex scientific data into clear insights for both scientific and lay audiences. Proven ability to collaborate effectively with investigators, cross-functional partners, and external stakeholders.

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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.

Please 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.

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