Associate Director, Non-Clinical Safety Assessment

Role Summary

The Non-Clinical Safety Assessment Representative within the Non-Clinical Development (NCD) team is accountable for representing the non-clinical safety function (toxicology) on asset development teams. The role reports to the Non-Clinical Safety Assessment Lead and participates in cross-functional development programs across discovery through early clinical development, including interactions with regulatory affairs, safety, pharmacovigilance, CMC, medical affairs, and business development.

Responsibilities

• Serves as the Non-Clinical Safety Assessment (toxicology) representative on interdisciplinary asset development teams (ADTs).
• Plans and executes non-clinical safety studies and assessments to support asset progression and meet project timelines.
• Acts as the subject matter expert in non-clinical toxicology in meetings with internal and external stakeholders.
• Author and review non-clinical CTD modules for regulatory submissions (e.g., IND, NDA) and other regulatory communications.
• Provide scientific and strategic non-clinical safety input into pipeline programs, business development activities, and existing product portfolios as an ADT representative.
• Serve as a subject matter expert for non-clinical development issues.
• Coordinate non-clinical pharmacology and toxicology studies at CROs in conjunction with Non-Clinical Operations.
• Assist in the preparation and review of study protocols and research reports.
• Authorship of non-clinical sections of IND, CTA, NDA, MAA, and relevant regulatory documents; support interactions with Health Authorities as needed.
• Ensure non-clinical studies comply with regulations, guidelines, and animal welfare standards.
• Prepare or review non-clinical, early clinical development or CMC documentation for regulatory submissions; participate in Health Authority interactions as needed.
• Contribute to regional or global product label reviews and updates, as appropriate.
• Engage and communicate effectively with regulators, scientific leaders, and physicians as needed.
• Support the product portfolio in line with GLP and Organon SOPs.

Qualifications

• PhD, DVM or equivalent degree in pharmacology, biology, physiology, biochemistry, chemistry, toxicology or related sciences.
• Board certification in toxicology a plus (e.g., DABT, ERT).
• Five to seven years of experience in the pharmaceutical or biotech industry with extensive knowledge of non-clinical safety assessment and drug development, including toxicology with competency in DMPK and pharmacology.
• Knowledge of non-clinical development and regulatory guidelines related to drug substance/product impurities and GxP.
• Experience reviewing and authoring non-clinical sections of regulatory dossiers (e.g., NDAs) and product labels, with agency interaction experience.
• Experience working in global project teams.
• Strong communication, collaboration, integrity, and interpersonal skills.
• Excellent organizational and interpersonal skills; ability to manage multiple projects and shifting priorities.
• Ability to articulate complex ideas clearly to non-technical audiences and analyze data from literature reviews and preclinical/clinical studies.
• Ability to prioritize data, drive results, and provide scientifically reasoned recommendations.

Skills

• Non-clinical toxicology expertise
• Regulatory documentation and submissions (IND, NDA, CTAs, etc.)
• Study design, protocol preparation, and study reporting
• Regulatory affairs collaboration and health authority interactions
• GLP compliance and SOP adherence
• Cross-functional collaboration and stakeholder engagement

Education

• PhD, DVM or equivalent in relevant life sciences

Additional Requirements

• Travel requirements as needed to support regulatory interactions and CRO coordination.
• Valid driving license where applicable.