Sr. Principal Scientist, Nonclinical Drug Safety

Merck•Upper Gwynedd Township, PA

5d•$190,800 - $300,300•Hybrid

About The Position

The Nonclinical Drug Safety (NDS) Therapeutic Area Leader (TAL) for Immunology is a senior scientific leader responsible for advancing NDS and the company’s goals in drug development, product registration, and post-marketing support. The role oversees nonclinical development programs and post-marketing support across the Immunology therapeutic area, using strong immunology expertise and knowledge of regulatory expectations to develop sound strategies from complex scientific information. The position provides scientific and strategic oversight of Immunology candidates and works closely with Program Coordinators, Discovery Preclinical Leaders, Compound Leaders, and scientists across NDS and Preclinical Development. It partners with Research and Development functions including Discovery, chemistry, regulatory affairs, translational medicine, clinical development, and CMC. The role also supports emerging discovery projects and may serve as a Compound Leader or oversee or conduct NDS due diligence for relevant in-licensing opportunities. The leader develops nonclinical strategies, risk assessments, and regulatory submissions for global clinical development, product registration, and post-marketing commitments. This includes mentorship on nonclinical program and toxicology study design, weight-of-evidence assessments, science-based waiver strategies, and integrated safety development plans. The position is accountable for scientifically robust, clear, and concise regulatory documentation and risk assessments supporting clinical trials, registration, and post-marketing activities. The role proactively identifies program issues, resource needs, priorities, and emerging risks, and guides Compound Leaders through ambiguity and complexity toward timely, risk-balanced resolutions. It actively coaches and mentors Compound Leaders and Discovery Program Leaders, fosters a culture of empowerment and accountability, and contributes to global nonclinical development strategy through publications, consortia, cross-industry collaborations, and internal cross-departmental initiatives. The role represents the company externally and helps maintain its scientific and regulatory reputation in immunology.

Requirements

PhD, DVM, and/or MD degree with graduate 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.
Demonstrated experience collaborating with and mentoring program team representatives.
Solid 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 and partnership-building skills in a matrixed environment, including the ability to influence strategic direction and foster mentorship, empowerment, accountability, talent growth, and program success.
Excellent organizational, verbal, and written communication skills, including the ability to deliver clear, concise, scientifically rigorous documents and presentations.
Experience authoring and critically reviewing nonclinical regulatory document sections, including Investigator Brochures, briefing books, INDs, CTAs, NDAs, BLAs, MAAs, regulatory responses, and related scientific or legal documents.
Required skills include Cell Line Engineering, Clinical Judgment, Drug Development, Human Health Risk Assessment, Innovative Thinking, Mentorship, Omics Technologies, Pharmacodynamics, Pharmacokinetics, Product Registrations, Project Leadership, Risk Assessments, Strategic Planning, Toxicity Studies, and Toxicology.

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 area, including experience influencing global regulatory strategy through scientific publication, 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 internal program leaders and scientists.
Partner with Discovery, chemistry, regulatory affairs, translational medicine, clinical development, CMC, and other Research and Development functions.
Identify potential program issues and guide Compound Leaders through ambiguity and complexity to reach timely, risk-balanced resolutions.
Coach and mentor Compound Leaders and Discovery Program Leaders, and foster a culture of 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 design, toxicology study design, weight-of-evidence risk assessments, science-based waiver strategies, and integrated safety development plans.
Ensure high-quality nonclinical risk assessments and regulatory documents, including descriptions of experimental design and results, scientific interpretations, and concise risk assessments.
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 for nonclinical drug development.
Potentially serve as a Compound Leader for assigned development compounds and oversee or conduct NDS due diligence reviews for Immunology-related in-licensing opportunities.
Represent the company’s immunology expertise and contribute to its external scientific and regulatory reputation.