Work Location: Remote

Summary:

Our client is seeking a highly experienced Fractional CSO/CMO to support a critical phase of its regulatory strategy. This is a targeted, high-impact engagement for a seasoned scientific and regulatory leader who can help build and execute a NAM-based development playbook for an upcoming FDA interaction.

The ideal candidate brings deep familiarity with FDA's evolving stance on New Approach Methodologies, a strong track record of pre-IND and IND-enabling work in oncology, and the ability to translate complex NAM-based science into a compelling, FDA-aligned regulatory narrative.

This is not a full-time role. Out partner is looking for a strategic thought partner and regulatory executor — someone who can step in, assess the current submission and development strategy, and help drive alignment with FDA on a NAM-forward development pathway.

Key Responsibilities

• Serve as scientific and regulatory lead for FDA engagement strategy, including preparation for a forthcoming pre-IND meeting
• Review and refine existing regulatory submissions and briefing documents to ensure NAM-based approaches are clearly articulated and defensible
• Design and validate weight-of-evidence strategies incorporating NAM-based data within a PK/PD analytical framework
• Advise on acceptable FDA methods for advancing a program without traditional animal studies, in alignment with FDA Modernization Acts 2.0 and 3.0
• Build the regulatory playbook for advancing NAM-based oncology programs through IND-enabling stages
• Translate complex scientific data into clear, FDA-ready language that supports alignment on innovative development pathways
• Support pre-IND meeting preparation, including briefing package development and anticipated FDA Q&A

Required Qualifications

• Proven experience in FDA oncology drug development with direct FDA engagement (pre-IND, IND-enabling, briefing packages)
• Deep expertise in New Approach Methodologies (NAMs), including validation, study design, and regulatory articulation
• Experience with patient-derived organoids (PDOs) strongly preferred
• Strong understanding of FDA Modernization Act 2.0 and 3.0 and the FDA Roadmap to Reducing Animal Testing
• Ability to construct and communicate NAM-based, weight-of-evidence toxicology and PK/PD strategies to regulatory audiences
• CSO or CMO-level mindset with the ability to operate as a strategic translator between science and FDA
• Experience working in or with virtual/asset-light biotech organizations preferred
• Candidate does not need product-specific knowledge — expertise in NAM methodology and FDA regulatory strategy is the priority

Ideal Profile

This person has sat across the table from FDA. They know how to frame a NAM-based approach in a way that earns alignment rather than skepticism. They're comfortable operating independently in a fractional capacity, can quickly get up to speed on the program, and are ready to help finalize a submission and prepare for a pivotal FDA interaction.

Published Category: Discovery Research & Preclinical