Legend Biotech · 6 hours ago
Sr. Medical Director, Drug Safety and Pharmacovigilance
Somerset, New Jersey, United States
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$286K/yr - $375K/yr
5+ years expLegend Biotech is a global biotechnology company dedicated to treating and curing life-threatening diseases. They are seeking a Sr. Medical Director, Drug Safety & Pharmacovigilance to provide safety strategy and guidance to the clinical development team, ensuring compliance with regulatory requirements and managing the safety profile of drug development projects.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
Responsibilities
Lead and support development of pharmacovigilance strategy and activities to ensure compliance with corporate clinical development and commercial goals
Conducting signal detection activities, include monitoring, evaluation, interpretation, management and communication of safety information
Responsible to conduct Safety Monitoring Team (SMT) meeting(s) to evaluate risk-benefit for the compounds with support from cross functional teams. Escalate and present unresolved safety issues to senior management in company governance meetings
Medical safety review including causality assessment of all available safety data generated from various sources (e.g. pre-clinical, clinical trial data, post-marketing and literature) throughout the development process for assigned compounds/projects
Provides medical expert safety review input into all critical documents for products in clinical development (e.g., INDs/NDA/BLA submissions, protocols and amendments, ICFs, IBs, and clinical research reports (CSR))
Identification and management of Urgent Safety Measures with support of cross functional team
Overview, and/or author aggregate reports and signal evaluation reports for assigned projects
Responsible for the Clinical content of responses to inquiries from regulatory authorities related to Safety topics
Provide leadership and support to Contract Research Organization (CRO) staff to ensure overall delivery of services. Ensures vendor oversight
Oversee and manage internal safety scientist and safety operation team
Assist with the writing and development of SOPs as required to ensure compliance to regulations and local laws, while maintaining clear instructions for procedures and activities to the achievement of company goals
Lead the development of a significant drug safety budget and effectively manage resources, funding and expenses
Lead high quality planning and execution of external meetings and internal stakeholder meetings (e.g., IMs, Governance, DMCs, SSC, Regulatory Authority meetings, etc.)
Demonstrated ability to build effective working relationships, influence, negotiate, and drive organizational engagement. Ability to be flexible and adapt quickly to the changing needs of the organization. Work closely with a key strategic alliance partner for projects that are being jointly developed
Identify project risks with input from the cross functional teams, and support resolving issues. Ensure that any potential delays are fully mitigated to avoid any delays with full transparency to senior leadership
Prepare/oversee monthly progress reports and ad-hoc reports as required
Support process improvement and functional training at departmental & company level
Assure that the highest quality, ethical & professional values are demonstrated in all aspects of the teamwork
Ensures compliance with corporate policies and procedures, as well as all related healthcare laws and regulations
Qualification
Required
MD or MBBS or MD-PhD or equivalent medical degree
5 or more years of pharmaceutical experience in Drug Safety & Pharmacovigilance
Strong understanding of pharmacovigilance regulations in the US and EU
Experience in supporting drug safety activities in registrational clinical studies
High level of medical competence, with an ability to balance this with industry standards to achieve business goals
Demonstrated skills in scientific analysis and reasoning
Sound knowledge of overall drug development process from discovery to registration and post marketing requirements & surveillance
Prior IND, as well as NDA/BLA (filing/submission) and other regulatory interaction experience is highly desirable
Strong track record of delivering results through effective team and peer leadership in matrix
Experience as a manager, plan and manage daily activities of team; coaches/mentors/trains team; leads performance management activity (goal setting, performance appraisals, etc.)
Excellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating important data into clinical strategies
Preferred
Experience in biotech - preferred but not required
Benefits
Medical, dental, and vision insurance
401(k)-retirement plan with company match that vest fully on day one
Equity and stock options
Eight weeks of paid parental leave after just three months of employment
Paid time off policy that includes vacation days, personal days, sick time, 11 company holidays, and 3 floating holidays
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
Commuter benefits
Family planning and care resources
Well-being initiatives
Peer-to-peer recognition programs
Company
Legend Biotech
Legend Biotech is a biopharmaceutical company that develops and commercializes novel cell therapies for oncology.
1001-5000 employees
H1B Sponsorship
Legend Biotech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (30)
2024 (11)
2023 (14)
2022 (7)
2021 (6)
2020 (13)
Funding
Current Stage
Public CompanyTotal Funding
$750.45M2023-05-05Post Ipo Equity· $350M
2022-07-25Post Ipo Equity· $250M
2020-06-05IPO
Leadership Team
Carlos Santos
Chief Financial Officer
Alan Bash
President, CARVYKTI
Recent News
2025-12-18
thefly.com
2025-12-09
Company data provided by crunchbase