Manager, Medical Affairs, Evidence Generation Operations
Legend Biotech
6 hours ago
Remote
United States
Medical Affairs
Role Overview
- Execute evidence generation activities within Legend Biotech’s US Medical Affairs organization, ensuring clinical research and evidence generation (including observational RWE studies and Investigator-Initiated Studies [IIS]) are completed efficiently, on time, and in full compliance with applicable regulations and company policies.
- Work under the strategic guidance of the Associate Scientific Director, RWE Generation, with hands-on trial execution.
- Collaborate cross-functionally with Medical Affairs, Clinical Operations, Regulatory, Data Management, Biostatistics, Pharmacovigilance, Compliance, and external partners to drive seamless study implementation and results dissemination.
Key Responsibilities
- Evidence Generation Project Management: Coordinate Medical Affairs–led evidence generation projects (RWE studies, IIS, and other observational research) aligned to Medical Affairs objectives, delivered on time, and fully compliant.
- Cross-Functional Coordination: Coordinate internal teams and external partners; ensure clear communication, timely issue resolution, and alignment on study plans.
- Site & Vendor Management: Oversee academic collaborators and vendors; anticipate/address risks and remove operational barriers.
- Budget & Resource Management: Manage budgets/resources; track spend and forecast needs; partner with Finance and Procurement for contracting and payments.
- Regulatory & Compliance: Ensure activities comply with regulatory guidelines (e.g., FDA, EMA) and internal standards; maintain audit-ready documentation.
- Data Quality and Reporting: Ensure data quality and reporting; partner with Biostatistics and Data Management; coordinate delivery of outputs (reports, abstracts, publications).
- Process Improvement: Identify gaps and standardize best practices/tools/templates.
Requirements
- Bachelor’s degree in life sciences/health sciences/related field; PharmD, PhD, MPH, or MS preferred.
- Minimum 2 years managing clinical research, clinical trial operations, or medical affairs studies; preference for IIS and/or RWE experience.
- Strong preference: oncology (hematology/oncology) or immunology; highly desirable: experience with cellular therapy research (CAR-T trials).
- Proven experience managing complex, cross-functional projects with budget/timeline oversight; experience supporting/coordinating IIS or collaborative research projects.
- Experience managing external research partners; ability to negotiate/manage study contracts, budgets, and vendor performance.
- Experience with compliance procedures and quality management; comfortable working within SOPs and supporting audits/inspections readiness.
- Strong understanding of clinical research methodologies, protocol development, and RWE/observational data management; familiarity with GCP, ICH, FDA/EMA regulations (and requirements for post-marketing research and IIS). Clinical trial software/collaboration tools familiarity is a plus.
- Proficiency with Microsoft Office 2013 (Outlook, Word, Excel, PowerPoint), SharePoint, Adobe Acrobat Professional, Concur, Veeva, and other PC-based applications; familiarity with AI platforms including Copilot.
- Excellent written/verbal communication; ability to translate complex scientific data for scientific and lay audiences; strong stakeholder collaboration.
- Execute evidence generation activities within Legend Biotech’s US Medical Affairs organization, ensuring clinical research and evidence generation (including observational RWE studies and Investigator-Initiated Studies [IIS]) are completed efficiently, on time, and in full compliance with applicable regulations and company policies.
- Work under the strategic guidance of the Associate Scientific Director, RWE Generation, with hands-on trial execution.
- Collaborate cross-functionally with Medical Affairs, Clinical Operations, Regulatory, Data Management, Biostatistics, Pharmacovigilance, Compliance, and external partners to drive seamless study implementation and results dissemination.
Key Responsibilities
- Evidence Generation Project Management: Coordinate Medical Affairs–led evidence generation projects (RWE studies, IIS, and other observational research) aligned to Medical Affairs objectives, delivered on time, and fully compliant.
- Cross-Functional Coordination: Coordinate internal teams and external partners; ensure clear communication, timely issue resolution, and alignment on study plans.
- Site & Vendor Management: Oversee academic collaborators and vendors; anticipate/address risks and remove operational barriers.
- Budget & Resource Management: Manage budgets/resources; track spend and forecast needs; partner with Finance and Procurement for contracting and payments.
- Regulatory & Compliance: Ensure activities comply with regulatory guidelines (e.g., FDA, EMA) and internal standards; maintain audit-ready documentation.
- Data Quality and Reporting: Ensure data quality and reporting; partner with Biostatistics and Data Management; coordinate delivery of outputs (reports, abstracts, publications).
- Process Improvement: Identify gaps and standardize best practices/tools/templates.
Requirements
- Bachelor’s degree in life sciences/health sciences/related field; PharmD, PhD, MPH, or MS preferred.
- Minimum 2 years managing clinical research, clinical trial operations, or medical affairs studies; preference for IIS and/or RWE experience.
- Strong preference: oncology (hematology/oncology) or immunology; highly desirable: experience with cellular therapy research (CAR-T trials).
- Proven experience managing complex, cross-functional projects with budget/timeline oversight; experience supporting/coordinating IIS or collaborative research projects.
- Experience managing external research partners; ability to negotiate/manage study contracts, budgets, and vendor performance.
- Experience with compliance procedures and quality management; comfortable working within SOPs and supporting audits/inspections readiness.
- Strong understanding of clinical research methodologies, protocol development, and RWE/observational data management; familiarity with GCP, ICH, FDA/EMA regulations (and requirements for post-marketing research and IIS). Clinical trial software/collaboration tools familiarity is a plus.
- Proficiency with Microsoft Office 2013 (Outlook, Word, Excel, PowerPoint), SharePoint, Adobe Acrobat Professional, Concur, Veeva, and other PC-based applications; familiarity with AI platforms including Copilot.
- Excellent written/verbal communication; ability to translate complex scientific data for scientific and lay audiences; strong stakeholder collaboration.