Sr. Principal Scientist, Nonclinical Drug Safety

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.

• 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.

• 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.

• 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.