Senior Director / Director, Non-Clinical Safety Project Specialist
Core
Lead non-clinical safety strategies, regulatory submissions, and project narratives to ensure safe progression of medicines through clinical development and approval.
Role type
Senior Director / Director, Non-Clinical Safety Project Specialist
Builds
Regulatory documents, project plans, and scientific narratives for drug development
Domain
Pharmaceutical/Biotech, Non-Clinical Safety, Drug Disposition
Deliverable
regulatory documents
Required skills
non-clinical safety strategy, regulatory submission leadership, cross-functional collaboration, complex data integration, scientific judgment, mentoring
Preferred skills
complex NCE/biologic modalities experience, specialist toxicology expertise, external scientific reputation, major initiative leadership
Technologies
CTA, IND, MAA, NDA
Responsibilities
Represent non-clinical safety in integrated project plans; lead design and delivery of non-clinical safety project plans; integrate scientific data into regulatory narratives; provide expert consultancy on target liabilities and safety screening; influence cross-functional stakeholders and regulators; support capability and quality across the PTM community; contribute to global regulatory submissions; lead major scientific or technical initiatives; ensure leadership on project safety issues; promote flexible scientific thinking.
Seniority
Senior Director, strategic leadership & cross-functional influence
