Executive Director, Medical Safety Strategy

EPM Scientific; Philadelphia (Philadelphia County); Sur place; USD 280 000 - 360 000; Plein temps

Résumé du poste

Confidential, AI-Enabled Biotechnology Company is seeking a Senior Director / Executive Director, Medical Safety Leader to provide medical and scientific leadership for an emerging portfolio targeting immunology, inflammation, and immune-mediated diseases.

The role reports to the Chief Medical Officer and demands governance discipline, global development experience, and hands-on leadership to scale safety capabilities in a rapidly growing biotech environment.

Qualifications

• MD or MD/PhD is required.
• Significant experience in Medical Safety/Pharmacovigilance within pharma/biotech.
• Experience leading global safety strategy and governance.
• Experience with DSURs/PSURs, regulatory submissions, and risk-management.
• Ability to influence senior stakeholders across functions and geographies.

Responsabilités

• Develop and lead the integrated medical safety strategy across the portfolio.
• Provide safety leadership from candidate selection through first-in-human studies and later-stage development.
• Define safety objectives, risks, monitoring plans, and evidence requirements.
• Translate safety data into recommendations for program teams and governance committees.
• Oversee safety review processes and escalation pathways across programs.
• Lead aggregate safety reporting and interactions with regulators.

Formation

MD or MD/PhD

Description du poste

Confidential, AI-Enabled Biotechnology Company is seeking a Senior Director / Executive Director, Medical Safety Leader to provide medical and scientific leadership for an emerging portfolio targeting immunology, inflammation, and immune-mediated diseases.

The role reports to the Chief Medical Officer and demands governance discipline, global development experience, and hands-on leadership to scale safety capabilities in a rapidly growing biotech environment.