Research Fellow, Pharma Toxicology

Responsibilities

• Lead nonclinical safety assessments strategies for pharmaceuticals, over the counter products, and consumer goods.
• Ensure that nonclinical development plans and their execution align with overall product development objectives, lifecycle management activities, and key regulatory expectations and milestones.
• Oversee the generation, interpretation, and communication of essential nonclinical data to enable successful clinical development, regulatory submissions/registrations, product launch, ongoing market support, and compliance activities.
• Provide guidance, coaching, and mentorship to junior team members to support their scientific and professional development. Manage toxicology staff.
• Stay current with evolving industry standards, regulatory guidance, and scientific best practices, integrating relevant updates into new product development and assessing their impact on existing products.
• Author, review, and approve technical documents and scientific reports as needed to support departmental deliverables.
• Collaborate and interface effectively with cross functional partners—including Product Development, Clinical Development, Analytical Chemistry, Regulatory Affairs, Quality, and Compliance—to support program objectives.
• Partner with international company sites to address nonclinical safety requirements for country specific submissions, registrations, and ongoing business needs.
• Lead the development, implementation, and continuous improvement of departmental processes, standards, and best practices.

Requirements

• Ph.D. in Toxicology or related discipline
• 12+ years of relevant Pharmaceutical industry experience.
• Experience in ophthalmology drug development is highly desirable.
• DABT preferred.