Senior/Executive Director, Neurotoxicology - Permanent - Remote

Proclinical is seeking a Senior/Executive Director in Neurotoxicology to lead and develop toxicology strategies for small molecule drug discovery programs. This role focuses on regulatory submissions from IND to NDA, ensuring compliance and strategic alignment with global standards.

Skills & Requirements:

Advanced degree in Toxicology, Pharmacology, Biology, or related field.Expertise in FDA, EMA, and ICH guidelines and GLP regulations.Experience in cross-functional drug development teams as a Safety Assessment lead.Proficiency in authoring regulatory submissions and responding to inquiries.Strong skills in outsourcing and monitoring toxicology studies.Effective communication and scientific writing skills.

The Senior/Executive Director, Neurotoxicology will:

Develop comprehensive toxicology strategies for global programs.Oversee nonclinical toxicology studies at external CROs, ensuring regulatory compliance.Lead the design and execution of GLP and non-GLP toxicology studies.Analyze toxicology data and author nonclinical sections for regulatory documents.Identify and manage risks in development programs with external expert consultation.Stay updated on CNS toxicological assessment literature and methodologies.Expand and maintain a network of external experts for strategic guidance.Collaborate across disciplines to integrate toxicology activities into project plans.Coordinate with global teams through virtual and in-person interactions.

If you are having difficulty in applying or if you have any questions, please contact Sofia Amark at s.amark@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.