Sr. Director Drug Safety & Pharmacovigilance (Head of Department) Fully Remote, USA Compensation: $265,000-280,000 + bonus + LTI Company Summary: This organization is a well-funded, clinical-stage biotechnology company focused on advancing a broad pipeline across autoimmune and inflammatory diseases. With multiple assets progressing through Phase 2 development and registrational studies on the horizon, the company is entering a critical stage of growth and value inflection. Recent financing has provided a strong capital runway to support late-stage development and continued expansion of the portfolio. Leadership is a key differentiator, with a CEO who has a proven track record of building and successfully exiting biotech companies, alongside a CMO widely recognized for driving multiple blockbuster approvals in the autoimmune space. The organization operates in a highly collaborative, science-driven environment where teams have meaningful ownership and visibility across programs. There is a clear focus on building scalable infrastructure while maintaining a hands-on, execution-focused culture. This is an ideal setting for individuals looking to step into a high-impact role where they can influence strategy, shape processes, and contribute directly to the advancement of clinically meaningful therapies. Responsibilities:

• Oversee global Safety and Pharmacovigilance activities, ensuring compliance with all regulatory requirements and guidance
• Lead oversight of adverse event case processing and aggregate safety reporting, ensuring high-quality, timely submissions to regulatory agencies and stakeholders
• Provide leadership on safety inputs across clinical and regulatory documents, including protocols, CSRs, investigator brochures, and submissions
• Partner closely with Clinical Leads and Medical Monitors to support medical review, safety assessments, and appropriate evaluation of adverse events
• Serve as the primary point of contact for internal teams and external partners on all Safety and PV-related matters
• Lead development and optimization of safety forms, templates, and processes, ensuring alignment with clinical operations across study start-up and execution
• Oversee Safety/PV vendors, ensuring performance, compliance, and high-quality data processing and reporting
• Ensure effective SAE reconciliation across clinical and safety databases
• Drive continuous improvement of PV systems, tools, and processes to support scalability and operational efficiency
• Support regulatory interactions, including responses to safety-related inquiries, inspections, and audit findings
• Contribute to development and maintenance of key safety documents, including core data sheets, labeling, and risk management plans
• Provide leadership and oversight to safety personnel, supporting performance, development, and a high-performing team environment
• Partner cross-functionally across Development, Regulatory, and other functional areas to support integrated program execution

Qualifications:

• M.D. or foreign equivalent
• 5+ years industry experience in Pharmacovigilance