Sr. Principal Scientist, Nonclinical Drug Safety

Merck•Upper Gwynedd Township, PA

4d•$190,800 - $300,300•Hybrid

About The Position

The Nonclinical Drug Safety (NDS) Therapeutic Area Leader for Immunology is a senior scientific leader responsible for advancing NDS and company goals in drug development, product registration, and post-marketing support. The role provides scientific and strategic oversight of immunology programs across discovery, development, registration, and post-marketing activities, and helps shape the external scientific and regulatory environment through engagement with health authorities, consortia, and scientific organizations. The position develops nonclinical strategies, risk assessments, and regulatory submissions; partners with Compound Leaders and cross-functional Research and Development teams; and guides nonclinical program and toxicology study design, waiver strategies, and integrated safety development plans. It also supports and mentors Compound Leaders and Discovery Program Leaders, leads strategic planning across immunology programs, and may serve as a Compound Leader or conduct due diligence reviews for in-licensing opportunities. The role contributes to global nonclinical strategy through publications and collaborations and may lead internal initiatives to improve policies, procedures, and strategic direction.

Requirements

PhD, DVM, and/or MD with graduate and/or post-graduate work and/or residency training in Toxicology, Immunology, Pharmacology, Pathology, or a related field.
At least 12 years of experience in toxicology, immunology, pharmacology, pathology, or a related field.
Pharmaceutical program team experience and demonstrated expertise in nonclinical drug development and/or relevant regulatory experience with a health authority.
Experience collaborating with and mentoring program team representatives.
Experience with regulatory processes, nonclinical risk assessments, ICH guidelines, and Good Laboratory Practice (GLP) requirements.
Expertise in nonclinical drug development across discovery, early development, and late development.
Strong scientific acumen, intellectual curiosity, persistence, and a track record of success across multiple phases of drug development.
Strong leadership skills and ability to build effective partnerships in a matrixed environment, influence strategic direction, and foster mentorship, empowerment, accountability, talent growth, and program success.
Excellent organizational, verbal, and written communication skills, including the ability to prepare clear, concise, scientifically rigorous documents and presentations.
Experience authoring and critically reviewing nonclinical sections of regulatory documents, including Investigator Brochures, briefing books, INDs, CTAs, NDAs, BLAs, MAAs, regulatory responses, and related scientific or legal documents.

Nice To Haves

Relevant graduate training in immunology and/or substantial experience providing program team representation or scientific oversight for immunology programs.
Experience in immunology and/or immuno-oncology drug development.
Experience supporting nonclinical development across multiple therapeutic modalities.
Leadership in a scientific expertise area and experience influencing global regulatory strategy through publications, external consortia, or cross-industry collaboration.
Experience coaching project team representatives with varying skill sets and serving on or providing strategic oversight to product development teams.
Experience supporting programs that have advanced to and/or achieved BLA or WMA.

Responsibilities

Serve as the NDS Therapeutic Area Leader for Immunology, overseeing nonclinical development programs and post-marketing support.
Deliver nonclinical strategies, risk assessments, and regulatory submissions supporting global clinical development, product registration, and post-marketing commitments.
Engage with health authorities, consortia, and scientific organizations to help shape the external scientific and regulatory environment.
Provide scientific and strategic oversight for immunology candidates in collaboration with Program Coordinators, Discovery Preclinical Leaders, Compound Leaders, and scientists across NDS and Preclinical Development.
Partner with Research and Development functions, including Discovery, chemistry, regulatory affairs, translational medicine, clinical development, and CMC.
Identify potential program issues and guide Compound Leaders through ambiguity and complexity toward timely, risk-balanced resolution.
Coach, mentor, and provide scientific leadership to Compound Leaders and Discovery Program Leaders.
Foster a leadership culture that balances coaching, empowerment, accountability, and talent development.
Plan strategically across immunology programs and identify resource needs, prioritization considerations, and emerging risks.
Mentor Compound Leaders on nonclinical program and toxicology study design, weight-of-evidence risk assessments, science-based waiver strategies, and integrated safety development plans.
Prepare and ensure the quality of nonclinical risk assessments and regulatory documentation for Investigator Brochures, CTAs, INDs, NDAs, BLAs, MAAs, regulatory responses, and other legal or scientific documents.
Collaborate with Discovery Program Leaders in NDS to provide scientific and strategic input on emerging immunology discovery projects.
Contribute to global nonclinical development strategy through scientific publications, external consortia, and cross-industry collaborations.
Lead internal cross-departmental initiatives to improve policies, procedures, and strategic direction.
As assigned, serve as a Compound Leader and/or oversee or conduct NDS due diligence reviews for immunology-related in-licensing opportunities.
Contribute to the company’s external scientific and regulatory reputation through immunology expertise.