Sr. Principal Scientist, Nonclinical Drug Safety
Merck
September 04, 2026
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Responsibilities:
- Serve as NDS Therapeutic Area Leader for Immunology; oversee nonclinical development and post-marketing support.
- Provide high-quality nonclinical strategies, risk assessments, and regulatory submissions supporting global clinical development, registration, and post-marketing commitments.
- Provide scientific/strategic oversight for Immunology programs; partner across R&D functions (Discovery, chemistry, regulatory affairs, translational medicine, clinical development, CMC).
- Lead situational decision-making, identify program issues, and guide Compound Leaders to timely, risk-balanced resolutions.
- Coach/mentor Compound Leaders and Discovery Program Leaders; foster coaching/empowerment/accountability culture.
- Drive strategic planning, resource needs, prioritization, and emerging risks across Immunology programs.
- Influence nonclinical drug safety considerations (tox study design, weight-of-evidence, waivers, integrated safety plans).
- Ensure accountability for high-quality nonclinical risk assessments and regulatory documentation (IBs, CTAs, INDs, NDAs, BLAs, MAAs, responses).
- Collaborate on emerging discovery projects; contribute to external/internal strategy via publications and collaborations.
- May act as Compound Leader and conduct NDS due diligence for in-licensing.
Qualifications:
- PhD/DVM/MD (or equivalent graduate/post-graduate/residency) in Toxicology, Immunology, Pharmacology, Pathology, or related field.
- 12+ years experience in relevant fields with pharmaceutical nonclinical drug development and/or regulatory experience.
- Experience mentoring program teams; strong regulatory/nonclinical risk assessment expertise, ICH, GLP.
- Demonstrated expertise across discovery/early/late development; preference for immunology training and/or immunology program oversight.
- Strong leadership, matrix partnership, and written/oral communication; author/review nonclinical regulatory document sections.
Preferred:
- Immunology/immuno-oncology; multiple modalities; BLA/WMA experience; leadership influencing global regulatory strategy.
Skills:
- Drug development, human health risk assessment, risk assessments, strategic planning, toxicology/toxicity studies, pharmacokinetics/pharmacodynamics, mentorship, project leadership; plus listed specialized skills.
Benefits/Pay (if applicable): $190,800–$300,300; annual bonus/long-term incentive (if applicable); medical/dental/vision, 401(k), paid time off.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Apply by the posting’s deadline; job end date: 09/25/2026 (effective through 11:59:59PM the day before).
- Serve as NDS Therapeutic Area Leader for Immunology; oversee nonclinical development and post-marketing support.
- Provide high-quality nonclinical strategies, risk assessments, and regulatory submissions supporting global clinical development, registration, and post-marketing commitments.
- Provide scientific/strategic oversight for Immunology programs; partner across R&D functions (Discovery, chemistry, regulatory affairs, translational medicine, clinical development, CMC).
- Lead situational decision-making, identify program issues, and guide Compound Leaders to timely, risk-balanced resolutions.
- Coach/mentor Compound Leaders and Discovery Program Leaders; foster coaching/empowerment/accountability culture.
- Drive strategic planning, resource needs, prioritization, and emerging risks across Immunology programs.
- Influence nonclinical drug safety considerations (tox study design, weight-of-evidence, waivers, integrated safety plans).
- Ensure accountability for high-quality nonclinical risk assessments and regulatory documentation (IBs, CTAs, INDs, NDAs, BLAs, MAAs, responses).
- Collaborate on emerging discovery projects; contribute to external/internal strategy via publications and collaborations.
- May act as Compound Leader and conduct NDS due diligence for in-licensing.
Qualifications:
- PhD/DVM/MD (or equivalent graduate/post-graduate/residency) in Toxicology, Immunology, Pharmacology, Pathology, or related field.
- 12+ years experience in relevant fields with pharmaceutical nonclinical drug development and/or regulatory experience.
- Experience mentoring program teams; strong regulatory/nonclinical risk assessment expertise, ICH, GLP.
- Demonstrated expertise across discovery/early/late development; preference for immunology training and/or immunology program oversight.
- Strong leadership, matrix partnership, and written/oral communication; author/review nonclinical regulatory document sections.
Preferred:
- Immunology/immuno-oncology; multiple modalities; BLA/WMA experience; leadership influencing global regulatory strategy.
Skills:
- Drug development, human health risk assessment, risk assessments, strategic planning, toxicology/toxicity studies, pharmacokinetics/pharmacodynamics, mentorship, project leadership; plus listed specialized skills.
Benefits/Pay (if applicable): $190,800–$300,300; annual bonus/long-term incentive (if applicable); medical/dental/vision, 401(k), paid time off.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Apply by the posting’s deadline; job end date: 09/25/2026 (effective through 11:59:59PM the day before).