Job description
Overview
Overview The Senior Director, Toxicology, is a key member of the nonclinical safety team, reporting to the Executive Director, Head of Toxicology and Molecular Mechanisms. In this role, you will represent toxicology at cross-functional project teams, strategize nonclinical safety data package, oversee safety pharmacology and toxicology studies, author nonclinical sections in regulatory submission documents, and address regulatory inquiries.
Responsibilities
Additional representative responsibilities will include, but not necessarily be limited to, the following:
Up to 5% travel
Overview The Senior Director, Toxicology, is a key member of the nonclinical safety team, reporting to the Executive Director, Head of Toxicology and Molecular Mechanisms. In this role, you will represent toxicology at cross-functional project teams, strategize nonclinical safety data package, oversee safety pharmacology and toxicology studies, author nonclinical sections in regulatory submission documents, and address regulatory inquiries.
Responsibilities
Additional representative responsibilities will include, but not necessarily be limited to, the following:
- Act as the primary representative for toxicology at cross-functional project teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the overall development strategy and timeline of candidate molecules.
- Provide strategic direction on toxicology from discovery throughout market application for programs in different therapeutic areas, ensuring alignment with company objectives and in compliance with regulatory guidelines and industry standards.
- Provide scientific guidance on study design, execution, and interpretation of nonclinical safety data; and oversee nonclinical safety studies outsourced to contract research organizations.
- Provide strategic input to project teams and senior management regarding the potential impact of toxicology results on Program and Clinical/Regulatory strategy.
- Author nonclinical sections in regulatory submission documents (e.g., IBs, INDs, CTAs, NDAs, BLAs, MAAs, PIPs, Scientific Advice, annual reports, and briefing documents).
- Contribute to issue-resolution teams, driving the scientific approach for toxicology issue resolution.
- Provide impurity safety assessment in support of CMC manufacturing and/or registration.
- Contribute to department SOPs and best practice documents.
- DVM, Ph.D., or equivalent in Toxicology or a related discipline. DABT/DACVP certification preferred.
- Minimum of 15 years of experience as a regulatory toxicologist (study director/monitor and/or project lead) in the pharmaceutical or biotechnology industry or within a regulatory authority.
- Proven track record of successfully leading toxicology programs through various stages of drug development.
- Experience in toxicology on biologics, oligonucleotides, and/or gene therapies is a plus.
- Advanced knowledge of toxicology, pharmacology, safety pharmacology & DMPK.
- Comprehensive knowledge of GLP regulations and all regulatory guidance related to the nonclinical evaluation.
- Passion for science with strong strategic thinking, critical thinking, and leadership skills.
- Agility to adapt to changes and flexibility to work across different time zones.
- Excellent interpersonal and communication skills.
Up to 5% travel