Sr. Principal Scientist, Nonclinical Drug Safety

Senior Principal Scientist leading nonclinical drug safety strategy for immunology programs at Merck. Responsible for overseeing development progression, regulatory submissions, and post-marketing support while mentoring scientists and influencing cross-functional partnerships across discovery through registration.

Responsibilities

• Oversee nonclinical development progression and post-marketing support for immunology therapeutic area programs
• Develop and deliver high-quality nonclinical strategies, risk assessments, and regulatory submissions supporting global clinical development and registration
• Provide scientific oversight and mentorship to compound leaders and program teams, guiding resolution of complex development issues
• Collaborate with discovery, regulatory affairs, translational medicine, and clinical development functions to ensure integrated safety development plans
• Lead strategic planning for immunology programs, identifying resource needs, prioritization, and emerging risks within the therapeutic area

Requirements

• PhD, DVM, or MD with graduate/postgraduate work in toxicology, immunology, pharmacology, pathology, or related field
• Minimum 12 years experience in toxicology, immunology, or related field with pharmaceutical program team and nonclinical development expertise
• Demonstrated expertise in nonclinical drug development across discovery, early, and late development phases
• Strong knowledge of regulatory processes, ICH guidelines, GLP requirements, and nonclinical risk assessment methodology
• Proven leadership skills and ability to build effective partnerships in matrixed environments
• Experience authoring and reviewing nonclinical regulatory documents (INDs, CTAs, NDAs, BLAs, MAAs, Investigator Brochures)
• Immunology program experience preferred; immuno-oncology drug development experience strongly preferred