About the role
Vice President, Nonclinical Development Vice President, Nonclinical Development BioAge Labs (BIOA) is finding new ways to treat disease by targeting the mechanisms of aging, with the ultimate goal of increasing healthy human lifespan. https://bioagelabs.com We are seeking an experienced VP of Nonclinical Development to join our growing team. Position Overview The Vice President, Nonclinical Development is a senior scientific leader responsible for defining and executing the non-clinical development strategy across the company’s portfolio. This role provides enterprise-level leadership for toxicology, DMPK, PK/PD, and translational pharmacology supporting both small molecule and biologic programs from candidate selection through clinical development. This individual will play a critical role in first-in-human dose selection, senior review of potential in-licensing opportunities, creation and review of documents in support of regulatory submissions, and partner with external resources and cross-functional stakeholders to align on strategic and operational framework. Key
Responsibilities Strategic Non-Clinical Leadership • Define and lead integrated non-clinical development strategies across toxicology, DMPK, and translational sciences. • Ensure alignment of non-clinical plans with clinical development strategy, regulatory
requirements, and corporate objectives. • Provide data-driven risk–benefit assessments to inform governance and portfolio decisions. Toxicology & Safety Assessment • Oversee design, execution, and interpretation of GLP toxicology, safety pharmacology, and other regulatory-enabling studies. • Lead mechanistic evaluation of safety findings and establish appropriate safety margins (NOAEL, MABEL) to support FIH and clinical dose escalation. • Direct safety strategy for biologics, including species relevance, immunogenicity risk, and target-mediated effects. DMPK, ADME & Quantitative Pharmacology • Lead DMPK strategy including ADME profiling, metabolite characterization, DDI risk assessment, and bioanalytical oversight. • Oversee PK/PD and model-informed drug development approaches (allometry, PBPK, exposure-response modeling) to support human PK prediction and dose optimization. Regulatory & Cross-Functional Leadership • Oversee preparation of non-clinical sections for IND/CTA, NDA/BLA, and global regulatory submissions. • Represent non-clinical strategy in regulatory agency interactions. • Partner closely with Clinical Development, Regulatory Affairs, CMC, Biometrics, and Research to ensure cohesive development plans. • Build and lead a high-performing preclinical organization and manage external CRO partnerships to ensure scientific excellence and operational rigor. Required Skills and Abilities Working knowledge of in modeling and simulation tools Experience authoring and providing critical technical reviews of regulatory documents, including IND and NDA’s. Excellent leadership skills and outstanding listening, written, and oral communication skills Proactive, strategic, and forward-thinking with the ability to analyze complex situations and propose solutions Proven ability to liaise with regulatory agencies in the US and internationally Proficiency in Microsoft Word, PowerPoint, some Excel