Sr. Scientific Director, Toxicology

Role: Senior Toxicology Leader responsible for developing and executing regulatory-compliant toxicology strategies across early discovery through clinical development. Responsibilities: oversee safety pharmacology and toxicology studies for diverse modalities including small molecules, biologics, gene therapies; interpret safety data, advise on program impact, and prepare regulatory submissions (INDs, CTAs, BLAs/NDAs/MAAs). Collaborate closely with R&D teams to integrate toxicology insights, de-risk safety liabilities, and support market authorization efforts. Lead SOP development, ensure regulatory compliance, and manage CRO relationships. Qualifications: PhD in Toxicology, Pathology or D.V.M. with 8+ to 10+ years in pharma/biotech nonclinical safety, preferably with expertise in biotherapeutics, oligonucleotides, gene therapies, and regulatory filings. Demonstrated leadership, strategic development, and global regulatory knowledge (FDA, EMA, Health Canada). Experience managing CROs and working with diverse modalities is essential. High-Value: nonclinical safety, biologics and gene therapies, regulatory strategy, IND/CTA/BLA/MAA preparation, GLP standards, CRO management, senior leadership collaboration. Location: unspecified, likely hybrid or onsite; travel not specified.