VP, Translational Science (Nonclinical) Development

Company

Fully integrated, commercial-stage biotechnology company focused on CNS and immunology treatments.

What you will do

• Set translational strategy and integrate discovery-to-development plans to progress programs from target identification through candidate selection and IND-enabling studies.
• Lead target validation, pharmacology, proof-of-concept, and candidate-enabling in vitro/in vivo studies for small molecules, biologics, and vaccines.
• Own biomarker strategy to support pharmacodynamic assessments, patient selection, and proof-of-mechanism.
• Design, execute, analyze, and report nonclinical toxicology (GLP and non-GLP) and oversee bioassay development/validation for GLP/GCP nonclinical and clinical studies.
• Serve as nonclinical executive sponsor on cross-functional program teams, driving risk mitigation, asset prioritization, and go/no-go decisions.
• Lead regulatory-facing nonclinical content for submissions and meetings with global health authorities (e.g., FDA, EMA), and manage CRO selection and performance.

Requirements

• PhD, PharmD, DVM, MD, or equivalent doctoral degree in pharmacology, toxicology, neuroscience, or a related discipline (DABT certification preferred).
• Minimum 15 years of progressive pharmaceutical/biotech R&D experience, including drug discovery, translational science, and nonclinical development, with 5+ years in leadership/executive role.
• Proven success leading programs from target identification/validation through candidate selection, IND-enabling studies, and clinical development.
• Strong ability to integrate pharmacology, toxicology, DMPK, biomarkers, and regulatory strategy into cohesive development plans.
• Experience supporting regulatory interactions (Pre-IND, IND, End-of-Phase, and global health authority meetings) and owning nonclinical content for submissions (IND/CTA/NDA/BLA).
• Ability to travel to internal sites and other business needs (up to 20%) as required by location leadership and company policies.

Culture & Benefits

• Comprehensive benefits including medical, dental, and vision insurance; life and disability coverage; Flexible Spending Accounts and Health Savings Account.
• 401k with company match and annual discretionary stock options.
• Generous paid time off, sick time, and paid holidays.
• Career development and training; Employee Assistance Programs.
• Equal employment opportunity and compliance with applicable nondiscrimination laws.

Hiring process

• Interviews focused on translational/nonclinical leadership, regulatory strategy, and cross-functional execution.
• Evaluation of experience leading programs through IND-enabling studies and regulatory interactions.
• Discussion of role expectations, including CRO/vendor management and cross-functional collaboration.

Location: Berkeley Heights, NJ; Frederick, MD

Salary: $285,000 - $380,000 USD