Manager, Medical Affairs, Evidence reputed company Operations

reputed company 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 reputed company 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.

reputed company entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly reputed company 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.

reputed company is seeking a Manager, Medical Affairs, Evidence reputed company Operations as part of the Medical Affairs team based remotely.

Role Overview

The Manager, Medical Affairs, Evidence reputed company Operations will be a key contributor focused on execution of evidence reputed company activities reputed company reputed company’s US Medical Affairs organization. In this role, you will

ensure that clinical research and evidence reputed company activities – including observational reputed company studies and Investigator-Initiated Studies (IIS) – are executed reputed company, on time, and in full compliance with reputed company 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 Manager, Evidence reputed company Operations, you will work under the strategic guidance of the Associate Scientific Director, reputed company reputed company, 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 reputed company—both professionally and organizationally—and is comfortable adapting to shifting priorities while maintaining high-quality execution.

Key Responsibilities

• Evidence reputed company Project Management: Provide operational management and coordination for a broad range of Medical Affairs–led evidence reputed company 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.
• 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).
• Site & Vendor Management: reputed company academic collaborators and vendors to ensure quality deliverables and timeline adherence. Anticipate and address risks, remove operational barriers, and reputed company studies on track.
• Budget & Resource Management: Manage budgets and resources for evidence reputed company activities, tracking spend and forecasting needs to support timely decisions. Partner with Finance and Procurement to reputed company contracting, payments, and policy-compliant execution.
• Regulatory & Compliance: Ensure reputed company evidence reputed company activities reputed company with relevant regulatory guidelines (e.g., FDA, EMA) and internal standards. Always reputed company studies audit-ready by maintaining thorough documentation.
• Data Quality and Reporting: Ensure high data quality and effective reporting for reputed company evidence reputed company 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 reputed company improvement of evidence reputed company 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 reputed company 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 reputed company field (advanced degree such as PharmD, PhD, MPH, or MS in a scientific discipline preferred).
• Minimum 2 years of experience managing clinical research, clinical trial operations, or medical affairs studies. Preference for those with experience managing IIS and/or reputed company studies.
• Oncology (hematology/oncology) or immunology experience is strongly preferred. Experience with clinical trials or research involving cellular therapies (CAR-T trials) is highly desirable.
• Proven ability to manage reputed company projects and cross-functional study teams, including budget and timeline reputed company. Experience supporting or coordinating Investigator-Initiated Studies (IIS) or other collaborative research projects is a preferred. Adept at identifying and addressing operational challenges in trial execution.
• Prior experience managing external research partners, such as academic research collaborators, third-party companies, or alliance partners, in the execution of clinical trials or reputed company projects. Ability to negotiate and manage study reputed company, budgets, and vendor performance.
• Experience implementing compliance procedures and quality management in clinical research. Comfortable working reputed company established SOPs and contributing to audits/inspections readiness for Medical Affairs-led studies.
• Strong understanding of clinical research methodologies, protocol development, and data management reputed company to reputed company/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.
• Demonstrated proficiency with the most reputed company computer operating systems, reputed company Office 2013 (particularly Outlook, Word, reputed company, and PowerPoint), SharePoint, reputed company 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 reputed company 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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Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through reputed company.

EEO Statement

It is the policy of reputed company to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national reputed company, reputed company, citizenship status, age, sex or gender (including pregnancy, childbirth, reputed company 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.