Senior Director, Development Pharmacology & Toxicology

Responsibilities

• Establish and direct platform-wide testing strategies across therapeutic modalities, proactively anticipating evolving guidance from FDA, EMA, ICH and other agencies to create innovative approaches for gene editing, nucleic acid, lipid nanoparticle, and AAV products.
• Lead development of compliance frameworks for Good Laboratory Practice (GLP) across multiple programs; integrate GMP considerations into nonclinical testing strategies to ensure seamless transition from early to late development.
• Guide design and oversee successful execution of critical nonclinical studies, including pivotal GLP toxicology studies in support of program advancement into and through clinical development.
• Shape industry best practices through external engagement and influence regulatory thinking around novel therapeutic modalities, positioning the company as a thought leader in the evolving regulatory landscape.
• Direct preparation and review of comprehensive regulatory submission packages, making final determinations on nonclinical content strategy for INDs, CTAs, BLAs, and NDAs across multiple programs simultaneously.
• Lead cross-functional initiatives with research, clinical development, manufacturing, regulatory affairs, and quality assurance to develop integrated approaches that enhance overall program strategy beyond individual regulatory considerations.
• Define strategic integration between Discovery PharmTox and Development PharmTox to ensure cohesive pipeline progression and seamless candidate transition, establishing long-term nonclinical development frameworks.
• Establish departmental priorities and resource allocation strategies in partnership with Preclinical Operations leadership to optimize organizational capabilities across the portfolio.
• Represent the company in critical regulatory agency interactions, presenting strategic positions at senior levels and negotiating complex scientific and regulatory matters with health authorities globally.
• Direct due diligence activities for potential partnerships, in-licensing, or acquisition opportunities, making recommendations that inform corporate development strategy and long-term portfolio planning.
• Serve as a key member of the R&D leadership team, contributing to organizational strategy and assuming broader responsibilities for VP, Pharmacology & Toxicology in their absence or upon delegation.

Requirements

• Comprehensive knowledge of IACUC, GLP, laboratory safety and data integrity standards to anticipate necessary resources
• Proficiency with Microsoft Word, Excel, Powerpoint, and MS Project
• Experience managing scientific projects in a highly matrixed organization; evidence of collaboration in multidisciplinary environment
• Experience managing rodent and large animal (e.g., non-human primate) studies
• Bachelor's, Master's, or PhD in pharmacology, toxicology or related field
• At least 15 years + BS, 12 yrs + MS, 10 yrs + PhD experience required
• At least 7 years supervisory experience required
• Prolonged periods of sitting at a desk and working on a computer