Sr. Principal Scientist, Nonclinical Drug Safety
Merck
September 04, 2026
Remote friendly (West Point, PA)
United States
Clinical Research and Development
Responsibilities:
- Serve as 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.
- Provide scientific and strategic oversight for Immunology candidates; collaborate with cross-functional R&D partners (Discovery, chemistry, regulatory affairs, translational medicine, clinical development, CMC).
- Provide situational leadership and innovative problem-solving; guide Compound Leaders through ambiguity to achieve timely, risk-balanced resolution.
- Coach, mentor, and develop Compound Leaders and Discovery Program Leaders; foster a culture of coaching, empowerment, accountability, and talent development.
- Lead strategic planning across Immunology programs; identify resource needs, prioritization, and emerging therapeutic area risks.
- Influence nonclinical drug safety considerations (program/toxicology design, weight-of-evidence risk assessments, waiver strategies, integrated safety plans).
- Account for high-quality nonclinical risk assessments and regulatory documentation (e.g., experimental design/results, interpretations, concise risks) for Investigator Brochures, CTAs, INDs, NDAs, BLAs, MAAs, and regulatory responses.
- Collaborate with Discovery Program Leaders on emerging Immunology discovery projects.
- Contribute to global nonclinical strategy via publications, consortia, and cross-industry collaboration; may lead internal initiatives to improve policies/procedures.
- May serve as Compound Leader and conduct NDS due diligence for in-licensing relevant to Immunology.
Qualifications:
- PhD, DVM, and/or MD with graduate/post-graduate training or residency in Toxicology, Immunology, Pharmacology, Pathology, or related field.
- Minimum 12 years in toxicology/immunology/pharmacology/pathology (or related), including pharmaceutical program team experience and nonclinical drug development and/or health authority regulatory experience.
- Experience collaborating with and mentoring program team representatives.
- Strong regulatory process knowledge; nonclinical risk assessments; ICH guidelines; GLP.
Preferred:
- Immunology and/or immuno-oncology drug development experience; multi-modality nonclinical development experience.
- Leadership influencing global regulatory strategy (publication/consortia/cross-industry).
- Experience coaching team representatives; supported programs reaching BLA or WMA.
Required Skills (examples): Cell line engineering, clinical judgment, drug development, human health risk assessment, mentorship, omics technologies, pharmacodynamics/pharmacokinetics, product registrations, project leadership, risk assessments, strategic planning, toxicity studies/toxicology.
Application instructions:
- Apply via https://jobs.merck.com/us/en (deadline per posting).
- Serve as 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.
- Provide scientific and strategic oversight for Immunology candidates; collaborate with cross-functional R&D partners (Discovery, chemistry, regulatory affairs, translational medicine, clinical development, CMC).
- Provide situational leadership and innovative problem-solving; guide Compound Leaders through ambiguity to achieve timely, risk-balanced resolution.
- Coach, mentor, and develop Compound Leaders and Discovery Program Leaders; foster a culture of coaching, empowerment, accountability, and talent development.
- Lead strategic planning across Immunology programs; identify resource needs, prioritization, and emerging therapeutic area risks.
- Influence nonclinical drug safety considerations (program/toxicology design, weight-of-evidence risk assessments, waiver strategies, integrated safety plans).
- Account for high-quality nonclinical risk assessments and regulatory documentation (e.g., experimental design/results, interpretations, concise risks) for Investigator Brochures, CTAs, INDs, NDAs, BLAs, MAAs, and regulatory responses.
- Collaborate with Discovery Program Leaders on emerging Immunology discovery projects.
- Contribute to global nonclinical strategy via publications, consortia, and cross-industry collaboration; may lead internal initiatives to improve policies/procedures.
- May serve as Compound Leader and conduct NDS due diligence for in-licensing relevant to Immunology.
Qualifications:
- PhD, DVM, and/or MD with graduate/post-graduate training or residency in Toxicology, Immunology, Pharmacology, Pathology, or related field.
- Minimum 12 years in toxicology/immunology/pharmacology/pathology (or related), including pharmaceutical program team experience and nonclinical drug development and/or health authority regulatory experience.
- Experience collaborating with and mentoring program team representatives.
- Strong regulatory process knowledge; nonclinical risk assessments; ICH guidelines; GLP.
Preferred:
- Immunology and/or immuno-oncology drug development experience; multi-modality nonclinical development experience.
- Leadership influencing global regulatory strategy (publication/consortia/cross-industry).
- Experience coaching team representatives; supported programs reaching BLA or WMA.
Required Skills (examples): Cell line engineering, clinical judgment, drug development, human health risk assessment, mentorship, omics technologies, pharmacodynamics/pharmacokinetics, product registrations, project leadership, risk assessments, strategic planning, toxicity studies/toxicology.
Application instructions:
- Apply via https://jobs.merck.com/us/en (deadline per posting).