Sr. Medical Director, Drug Safety and Pharmacovigilance

Legend Biotech is seeking a Sr. Medical Director, Drug Safety & Pharmacovigilance as part of the Clinical Development Team working in Somerset, NJ. 

Role Overview

The Sr. Medical Director, Drug Safety & Pharmacovigilance is a critical role in the company with significant impact on the development and life cycle of drug development projects. Responsible for providing safety strategy, expertise and guidance to the clinical development and project team for the assigned products. The Sr. Medical Director will drive the proactive implementation of risk management initiatives in accordance with global regulatory requirements. Core responsibilities will encompass continuous and efficient evaluation of safety data, perform signal detection, evaluation and assessment and management of the safety profile of the compound. In addition, the position will ensure program consistency & alignment across studies, working closely with cross functional teams for achieving project goals, within timelines & with high quality.

Key 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

Requirements

• 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.
• Experience in biotech - preferred but not required.

#Li-LB1

#Li-Hybrid