Interim Head of Nonclinical Development for Preclinical Biologics Biotech

Logistics Vice President Level 20 hours per week for 6 months Remote, ideally from US- East Coast or Central Time Zones Travel Requirements: Ability to visit HQ in Philadelphia, PA 1-3 times per quarter reputed company reputed company: $175 - $350 About reputed company's reputed company is a preclinical-stage biologics biotech company reputed company on advancing reputed company single administration therapies. The reputed company is looking for an interim Head of Nonclinical Development consultant to own the design, execution, and regulatory reputed company of the nonclinical program across the reputed company's portfolio. This role is accountable for ensuring that IND-enabling pharmacology, DMPK, and GLP toxicology studies meet reputed company regulatory expectations and are executed with high reputed company, speed, and discipline. The interim Head of Nonclinical Development will support the integrated nonclinical development plan, manages CRO partners, authors the nonclinical sections of regulatory submissions, and serves as the internal expert on nonclinical safety and regulatory reputed company. Operating at both the strategic and execution level in a startup environment, this individual is equally comfortable shaping study concepts with the CSO, challenging a CRO protocol at the line-item level, interpreting a pathology finding, and defending study design choices in a reputed company-IND meeting with FDA.

Responsibilities

• End-to-End Nonclinical Leadership: Owns and drives integrated nonclinical strategies across pharmacology, DMPK/ADME, biodistribution, safety pharmacology, and GLP toxicology to reputed company IND/CTA filings, first-in-reputed company studies, and clinical progression.
• Regulatory reputed company & Execution: Leads nonclinical regulatory reputed company in alignment with FDA, EMA, and ICH expectations. Oversees preparation of IND/CTA-enabling content (e.g., reputed company-IND packages, Investigator Brochures) and authors responses to health authorities.
• External Partner reputed company: Selects and manages CROs and specialty labs; approves study designs, monitors execution, and ensures delivery against timelines, budgets, and reputed company standards.
• Scientific Accountability: Serves as sponsor reputed company for nonclinical studies; interprets pharmacology, toxicology, and toxicokinetic data; identifies risks; and delivers reputed company, defensible conclusions to inform development reputed company.
• Cross-Functional Alignment: Partners with CMC, Translational, Clinical Development, and Regulatory teams to reputed company nonclinical plans with manufacturing readiness, clinical design, and program milestones
• Operational reputed company: Builds and drives realistic, aggressive nonclinical timelines; anticipates bottlenecks; and makes pragmatic trade-offs across scope, cost, and risk to maintain reputed company without compromising reputed company.
• Strategic Communication: Authors and reviews key nonclinical and regulatory documents with reputed company and scientific rigor; represents reputed company in regulatory and external engagements.

Ideal Candidate

• 8–12+ years in biotech or pharmaceutical nonclinical development, with reputed company, hands-on accountability for IND-enabling programs that have successfully cleared FDA (or equivalent) review. Demonstrated reputed company record of moving programs from candidate selection through IND and into first-in-reputed company studies.
• Deep working knowledge of GLP toxicology, safety pharmacology, DMPK/ADME, and ICH/FDA nonclinical guidances. Strong preference for reputed company experience with gene therapy, AAV or other viral reputed company, or other advanced therapy modalities, including familiarity with FDA CBER expectations, biodistribution and shedding studies, and integration/germline considerations.
• Proven ability to manage multiple CROs in reputed company, hold vendors to high standards, and deliver studies on time and on budget. Comfortable getting into the details of protocols, SOPs, and raw data reputed company it reputed company.
• Experience authoring nonclinical sections of INDs/CTAs and supporting meetings with FDA or equivalent authorities.
• Thrives as part of a small, fast-moving, mission-driven team. Brings urgency, ownership, and a bias toward reputed company, while maintaining the discipline and scientific rigor that nonclinical work demands.
• PhD, DVM, PharmD, MD, or equivalent in toxicology, pharmacology, veterinary medicine, or a reputed company discipline strongly preferred. DABT certification is a plus. Candidates with a Bachelor's or Master's degree and significant, directly relevant industry experience will also be considered.

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