Sr. Principal Scientist, Nonclinical Drug Safety

Job Description

The Nonclinical Drug Safety (NDS) Therapeutic Area Leader (TAL) is a senior scientific leader responsible for advancing the vision and goals of NDS and our company as an industry leader in drug development, product registration, and post-marketing support.

Responsibilities include the following:

• •Serve as the NDS Therapeutic Area Leader for Immunology, overseeing the progression of nonclinical development programs and post-marketing support within the therapeutic area. The role requires strong scientific acumen in immunology, a deep understanding of regulatory expectations for immunology programs, and the ability to rapidly integrate complex scientific concepts into sound development strategies.
• •Deliver high-quality nonclinical strategies, risk assessments, and regulatory submissions that support global clinical development, product registration, and post-marketing commitments, while helping shape the external scientific and regulatory environment through engagement with health authorities, consortia, and scientific organizations.
• •Provide scientific and strategic oversight for Immunology candidates through close collaboration with Program Coordinators, Discovery Preclinical Leaders, Compound Leaders, and scientists across NDS and/or Preclinical Development, while ensuring strong partnership with key Research and Development Division functions, including Discovery, chemistry, regulatory affairs, translational medicine, clinical development, and CMC.
• •Demonstrate situational leadership and innovative problem-solving, with impact beyond Program Development, by proactively identifying potential program issues and guiding Compound Leaders through ambiguity and complexity to achieve timely, risk-balanced resolution.
• •Maintain a strong commitment to the development of Compound Leaders and Discovery Program Leaders through active coaching, mentoring, and scientific leadership.
• •Foster a leadership culture that balances coaching, empowerment, accountability, of thought, and talent development to enable both individual growth and program success.
• •Ensure strategic planning across Immunology programs and proactively identify resource needs, prioritization considerations, and emerging risks within the therapeutic area.
• •Strategically influence nonclinical drug safety considerations for Immunology programs by providing drug development mentorship and partnering with Compound Leaders on time-critical matters, including nonclinical program design and toxicology study design, weight-of-evidence risk assessments, science-based waiver strategies, and integrated safety development plans that support clinical trials, global registration, and timely resolution of nonclinical development issues.
• •Be accountable for high-quality nonclinical risk assessments and regulatory documentation, including clear descriptions of experimental design and results, scientifically robust interpretations, and concise risk assessments for Investigator Brochures, CTAs, INDs, NDAs, BLAs, MAAs, regulatory responses, and other legal or scientific documents supporting global clinical trials, registration, and post-marketing activities.
• •Collaborate closely with Discovery Program Leaders in NDS to provide scientific and strategic input on emerging discovery projects within the Immunology therapeutic area.
• •Contribute to global nonclinical development strategy through scientific publications, external consortia, and cross-industry collaborations, and proactively lead internal cross-departmental initiatives to improve policies, procedures, and strategic direction to maintain our company's leadership in nonclinical drug development.
• •May serve as a Compound Leader for assigned development compounds and may oversee or conduct NDS due diligence reviews for in-licensing opportunities relevant to the Immunology therapeutic area.
• •Be recognized for immunology expertise and contribute to our company's external scientific and regulatory reputation.

Required Education, Experience, and Skills:

PhD, DVM, and/or MD degree with graduate and/or post-graduate work and/or residency training in Toxicology, Immunology, Pharmacology, Pathology, or a related field.

• •Minimum of 12 years of experience in toxicology, immunology, pharmacology, pathology, or a related field, with pharmaceutical program team experience and demonstrated expertise in nonclinical drug development and/or relevant regulatory experience with a health authority.
• •Demonstrated experience collaborating with and mentoring program team representatives.
• •Solid experience with regulatory processes, nonclinical risk assessments, ICH guidelines, and Good Laboratory Practice (GLP) requirements.
• •Demonstrated expertise in nonclinical drug development across discovery, early development, and late development, with a strong preference for relevant graduate training in immunology and/or substantial experience providing program team representation or scientific oversight for immunology programs.
• •Strong scientific acumen, intellectual curiosity, persistence, and a demonstrated track record of success across multiple phases of drug development.
• •Strong leadership skills and the ability to build effective partnerships in a matrixed environment; demonstrated ability to collaboratively influence strategic direction and foster a culture of mentorship, empowerment, accountability, talent growth, and program success.
• •Excellent organizational skills and strong verbal and written communication capabilities, with the ability to develop and deliver clear, concise, and scientifically rigorous nonclinical 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.

Preferred Experience and Skills:

• •Experience in immunology and/or immuno-oncology drug development.
• •Experience supporting nonclinical development across multiple therapeutic modalities.
• •Demonstrated leadership in an area of scientific expertise, with experience influencing global regulatory strategy through scientific publication, external consortia, or cross-industry collaboration.
• •Previous experience coaching project team representative with varying skill sets and serving on or providing strategic oversight to product development teams.
• •Supported programs that have advanced to and/or achieved BLA or WMA

Required Skills:

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, Toxicology

Preferred Skills:

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