Sr. Principal Scientist, Nonclinical Drug Safety

MSD•Upper Gwynedd Township, PA

5d•$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 the company’s goals in drug development, product registration, and post-marketing support. The role oversees nonclinical development programs and post-marketing support in Immunology, applying strong scientific expertise and knowledge of regulatory expectations to develop sound strategies. The leader provides scientific and strategic oversight of Immunology candidates and works with program, discovery, compound, and NDS teams, as well as partners across Discovery, chemistry, regulatory affairs, translational medicine, clinical development, and CMC. The position shapes nonclinical development strategy, provides risk assessments and regulatory documentation, mentors program leaders, and proactively addresses program risks and resource needs. The role may also serve as a Compound Leader and may oversee or conduct NDS due diligence reviews for relevant in-licensing opportunities. The position contributes to global nonclinical development strategy through publications, external consortia, cross-industry collaborations, and internal cross-departmental initiatives. It also represents the company’s Immunology expertise externally and supports global clinical development, registration, and post-marketing activities.

Requirements

PhD, DVM, and/or MD with graduate and/or post-graduate work 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 health authority regulatory experience.
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 demonstrated record of success across multiple drug development phases.
Strong leadership skills and ability to build effective partnerships in a matrixed environment, influence strategic direction collaboratively, and foster mentorship, empowerment, accountability, talent growth, and program success.
Excellent organizational, verbal communication, and written communication skills, including the ability to develop and deliver 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.
Required skills listed: 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 representing program teams or providing scientific oversight for Immunology programs.
Experience in immunology and/or immuno-oncology drug development.
Experience supporting nonclinical development across multiple therapeutic modalities.
Demonstrated leadership in a scientific 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.
Develop high-quality nonclinical strategies, risk assessments, and regulatory submissions that support 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, NDS scientists, and Preclinical Development colleagues.
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 resolutions.
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.
Advise on nonclinical program and toxicology study design, weight-of-evidence risk assessments, science-based waiver strategies, and integrated safety development plans.
Prepare and ensure high-quality nonclinical risk assessments and regulatory documentation, including descriptions of experimental design and results, scientific interpretations, and concise risk assessments.
Support Investigator Brochures, CTAs, INDs, NDAs, BLAs, MAAs, regulatory responses, and other legal or scientific documents for global trials, registration, and post-marketing activities.
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.
Potentially serve as a Compound Leader for assigned development compounds and oversee or conduct NDS due diligence reviews for Immunology-related in-licensing opportunities.
Contribute to the company’s external scientific and regulatory reputation as an Immunology expert.