Safety Medical Director

Essential Duties and Responsibilities

• Lead signal detection activities, including monitoring, evaluation, interpretation, management, and communication of safety information.
• Conduct Safety Monitoring Team (SMT) meetings 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.
• Oversee 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.
• Provide 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)).
• Identify and manage Urgent Safety Measures with support of cross-functional team.
• Oversee and/or author aggregate reports and signal evaluation reports for assigned projects.
• Perform medical review of ICSR.
• Oversee and provide strategic direction to safety scientists, medical reviewers, and pharmacovigilance operations team, including vendor oversight.
• Contribute to the development and continuous improvement of pharmacovigilance systems, including SOPs, work instructions, and business processes.
• Ensure compliance with global pharmacovigivalence regulations and contribute to inspection readiness, audits, and regulatory inspections.
• Contribute to the development and continuous improvement of pharmacovigilance systems, including SOPs, work instructions, and business processes.
• Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Medical Affairs, and external partners to ensure alignment on safety strategies.
• Maintain deep and current knowledge of safety regulations, drug development processes, and therapeutic area science.

Knowledge/Skills/Abilities Required

• MD with 8-12 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.
• 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.
• An adaptable, detail-oriented leader with a collaborative spirit who excels at managing high-pressure situations and consistently delivering results within tight timelines.