Senior Director, Nonclinical Development

Role Overview

The Senior Director, Nonclinical Development serves as the regulatory lead for nonclinical (pharmacology–toxicology) and IND-enabling strategy for cell and gene therapy programs regulated by FDA/CBER. This role owns nonclinical regulatory positioning and IND execution, leads pharm/tox interactions with FDA, and provides regulatory support to CMC for lentivector-enabled products. The position partners closely with Clinical leadership, and is accountable for program-level regulatory outcomes through IND submission and early clinical development.

Location

Onsite, West Palm Beach, FL (relocation support provided)

Reports to

Chief Medical Officer

Company Overview

Innovative biotechnology company developing next-generation cell and gene therapy platforms for oncology applications.

Core Responsibilities

• Nonclinical / Pharm/Tox Regulatory Leadership

• Own regulatory strategy for nonclinical development, including pharmacology, toxicology, biodistribution, shedding, persistence, and related safety considerations.
• Partner with nonclinical scientists and CROs to ensure CBER-aligned study design supporting first-in-human dosing and IND readiness.
• Serve as primary author and reviewer for Nonclinical IND modules.

• IND Strategy & Execution

• Lead IND-enabling regulatory strategy, including content planning, sequencing, and risk framing.
• Drive preparation for INTERACT, pre-IND, and Type B FDA meetings, with primary responsibility for nonclinical and IND-enabling topics.
• Carefully coordinate FDA responses related to nonclinical or IND-level feedback and amendments.

• CMC Regulatory Support (Non-Owning)

• Provide regulatory input to CMC teams to ensure alignment between nonclinical safety assumptions, IND positioning, and manufacturing attributes.
• Review CMC content for consistency with dose justification, nonclinical relevance, and IND strategy.
• Partner closely with CMC regulatory leads but do not own final CMC regulatory decisions.

• FDA / CBER Engagement

• Represent Regulatory Affairs for pharm/tox and IND topics in FDA interactions.
• Translate FDA feedback into clear implications for study design, timelines, and program risk.

• Cross-Functional Collaboration

• Integrate regulatory considerations across Nonclinical, Clinical, CMC, Quality, and Program Management.
• Manage external consultants and CRO regulatory deliverables as needed.

Qualifications

• PhD, PharmD, or MD in pharmacology, toxicology, or a related scientific discipline.

• 10–14+ years regulatory experience in biotech or pharma with a strong cell and gene therapy focus.

• Demonstrated ownership of nonclinical regulatory strategy and IND submissions under FDA/CBER.

• Hands-on experience with lentivector-enabled products, including regulatory interpretation of nonclinical safety data.

• Direct experience supporting or leading FDA interactions for IND-enabling programs.

About Mix Talent

Mix Talent is a specialized recruiting partner focused on building high-performing teams across the life sciences industry. We partner closely with innovative pharma, biotech, and medical device companies to identify talent that drives meaningful impact.

Equal Opportunity Employer

The company is an equal opportunity employer and is committed to building a diverse and inclusive team. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.