Sr. Principal Scientist, Nonclinical Drug Safety
Merck · West Point, PA +1 more
SafetyFull-time$191k–$300kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
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.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
This role links to Merck's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.