VP, Nonclinical Development & Regulatory Strategy

Divergence Labs; New York (NY); On-site; USD 260,000 - 360,000; Full time

Job summary

Divergence Labs is seeking a full-time Director/VP of Nonclinical Development to own nonclinical development and regulatory strategy across our candidate molecules. The role requires 10+ years in biologics with IND/CTA experience and oversees CROs, regulatory interactions, and cross-functional collaboration to drive first-in-human programs.

The ideal candidate will lead a small integrated team, write nonclinical sections for briefing packages, and shape automation of development processes with

Qualifications

• PhD/PharmD/DVM/MD with 10+ years in nonclinical development and/or regulatory affairs for biologics.
• Led nonclinical package for at least one biologic through IND/CTA approval.
• Experience planning and leading formal agency interactions (pre-IND, scientific advice) and authoring briefing packages.
• Hands-on CRO management: study design, protocol review, monitoring, data review and budget ownership.
• Knowledge of PK/PD, DMPK, bioanalytical methods and GLP requirements.
• Experience with nonhuman primate and rodent toxicology programs, including dose-range finding.

Responsibilities

• Own the nonclinical development strategy for each program, aligning pharmacology, PK/PD, safety pharmacology and GLP toxicology with regulatory plans.
• Design and oversee CRO studies; select models; manage data, and finalize reports across therapeutic areas.
• Lead regulatory strategy and agency interactions; support pre-IND and submissions end-to-end.
• Author nonclinical overviews, summaries, and study reports and contribute to Investigator's Brochures.
• Set first-in-human dose and exposure margin analyses with clinical teams.
• Build and manage external network of CROs; ensure GLP compliance and on-time delivery.
• Collaborate with discovery and CMC to align with developability and testing in toxicology.
• Establish function standards, SOPs and data/document control.
• Lead and grow a small, high-caliber nonclinical and regulatory team.

Skills

Nonclinical development

Regulatory strategy

Biologics IND/CTA

CRO management

Regulatory writing

Education

PhD/PharmD/DVM/MD in toxicology or related field

Job description

Divergence Labs is seeking a full-time Director/VP of Nonclinical Development to own nonclinical development and regulatory strategy across our candidate molecules. The role requires 10+ years in biologics with IND/CTA experience and oversees CROs, regulatory interactions, and cross-functional collaboration to drive first-in-human programs.

The ideal candidate will lead a small integrated team, write nonclinical sections for briefing packages, and shape automation of development processes with