Director – Toxicology Project Lead

Director – Toxicology Project Lead

Requirements

• Ph.D., DVM, or equivalent in Toxicology, Veterinary Pathology or a related discipline; DABT/DACVP/ERT or equivalent certification is strongly preferred.
• Minimum of 10 years as a regulatory toxicologist (study director/monitor and project lead) or pathologist in the pharmaceutical or biotechnology industry.
• Demonstrated success in leading toxicology programs through various stages of drug development, with experience in biologics, oligonucleotides, and/or gene therapies being highly advantageous.
• Advanced knowledge of safety pharmacology, drug metabolism and pharmacokinetics, toxicology, and pathology.
• Thorough understanding of GLP regulations and nonclinical evaluation guidelines across different regulatory landscapes.
• Strategic and critical thinking with robust scientific acumen and proven problem-solving skills.
• Strong leadership capabilities with the ability to effectively influence cross-functional teams and collaborators.
• High adaptability to changing project requirements and the ability to manage work across various time zones.
• Excellent interpersonal, communication, and presentation skills, with a strong collaborative approach!
• Willingness to travel on business (up to 15%) both domestically and internationally.

Responsibilities

• Act as the primary toxicology representative on project teams, collaborating closely with discovery, bioanalysis, pharmacokinetics, clinical development, manufacturing, and program management to shape and drive project strategy and timelines.
• Lead the formulation and execution of comprehensive nonclinical safety strategies from discovery through to market application, ensuring alignment with regulatory guidelines and corporate objectives.
• Provide scientific direction on the design, execution, and interpretation of safety pharmacology and toxicology studies, ensuring high-quality, reliable data generation.
• Author and review nonclinical sections of regulatory submissions (e.g., IBs, INDs, CTAs, NDAs, BLAs, MAAs, PIPs, annual reports, briefing documents) and contribute to scientific advice preparation.
• Represent toxicology in meetings with global regulatory authorities, addressing inquiries and guiding discussions on nonclinical safety data.
• Lead issue-resolution initiatives, offering scientific expertise and strategic recommendations to address safety concerns.
• If appropriate, serve as peer review pathologist to toxicology studies conducted at CROs.
• Conduct impurity safety assessments, providing guidance to support setting specification limits in manufacturing processes and regulatory submissions.
• Contribute to improving departmental SOPs and standard methodology documents, improving operational efficiency and upholding high-quality standards.
• Maintain the state-of-art scientific and regulatory advancement in safety pharmacology and toxicology.

Preferred Qualifications

• DABT/DACVP/ERT or equivalent certification is strongly preferred.
• Experience in biologics, oligonucleotides, and/or gene therapies being highly advantageous.