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, registration, and post-marketing commitments; engage with health authorities/consortia.
• Provide scientific/strategic oversight for Immunology candidates in collaboration with Program Coordinators, Discovery Preclinical Leaders, Compound Leaders, and cross-functional R&D partners.
• Lead situational problem-solving to identify program issues and guide resolution through ambiguity/complexity.
• Coach/mentor Compound Leaders and Discovery Program Leaders; foster a coaching/empowerment/accountability culture.
• Drive strategic planning across Immunology programs; identify resource needs, prioritization, and emerging risks.
• Influence immunology nonclinical drug safety via mentorship and partnership on toxicology study design, WoE risk assessments, waiver strategies, and integrated safety plans.
• Ensure high-quality nonclinical risk assessments and regulatory documentation for Investigator Brochures, CTAs, INDs, NDAs, BLAs, MAAs, and regulatory responses.
• Contribute to global nonclinical strategy via publications and collaborations; lead internal initiatives to improve nonclinical policies/procedures.
• May serve as a Compound Leader and conduct NDS due diligence for relevant in-licensing.

• PhD/DVM/MD with training in Toxicology, Immunology, Pharmacology, Pathology, or related field.
• 12+ years in relevant field with pharmaceutical program team experience and nonclinical drug development and/or regulatory experience.
• Regulatory processes, ICH guidelines, GLP, and nonclinical risk assessment expertise.
• Strong leadership in matrixed environments; clear scientific communication and document authoring/review experience.

• Immunology/immuno-oncology experience; multiple modalities; leadership influencing global regulatory strategy.
• Coaching/strategic oversight; programs advancing to BLA/WMA.

• Cell line engineering; human health risk assessment; drug development; mentorship; PD/PK; product registrations; risk assessments; strategic planning; toxicity studies/toxicology; innovative thinking; project leadership; omics technologies; clinical judgment.