Job Description

Director, Occupational Toxicologist

General Summary:

This position is responsible for establishing and managing a global occupational and environmental toxicology program. The individual will be required to provide stewardship and support for Vertex's project portfolio. The individual will be part of the global environmental health and safety (EHS) team responsible for setting standards, developing culture and programs establishing health-based exposure limits for various applications.

Key Duties and Responsibilities:

• Develop an internal health based occupational exposure limit banding system and associated documentation.
• Generate and maintain occupational exposure banding documents (OEB), occupational exposure limit (OEL) monographs and safety data sheets for active pharmaceutical ingredients and biologically derived compounds.
• Maintain status tracker for occupational safety documentation needs for discovery and development assets in the portfolio
• Generate and maintain permitted/accepted daily exposure (PDE/ADE) documents.
• Provide support to external business activities as required (toxicological information, intake questionnaires, etc.).
• Ensure compliance with product related environmental regulations and prepare submittals for (REACH, CLP, TSCA).
• Work collaboratively with key stakeholders such as EHSS, Regulatory Affairs, Medical Safety, Pre-clinical Safety, CMC, Legal and Business Development.
• Stay current with proposed international laws and regulations to ensure Vertex meets requirements.

Knowledge and Skills:

• Comprehensive knowledge in applicable regulations and best practices as it pertains to product safety.
• Outstanding interpersonal, oral and written communication skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity
• Excellent management skills with a collaborative approach to problem solving, driving performance and success in a global environment
• Possesses excellent organizations skills and ability to manage priorities effectively
• Self-motivated, able to work independently and prioritize tasks to meet timelines
• Works effectively with cross-functional teams across multiple sites and cultures
• In silico safety assessment experience (e.g. DEREK, SARAH, Leadscope)

Education and Experience:

• Bachelor's Degree in Toxicology, Pharmacology, Biology, Biochemistry or related discipline is required.
• PhD in Toxicology or related field.
• Certification by the American Board of Toxicology or equivalent.
• A minimum of 10 years' experience as an occupational toxicologist in pharmaceutical/biotech/agrochem industry or consulting role.
• Experience in assignment of OELs, OEBs, ADEs and performing in-silico toxicity prediction
• Experience in critical evaluation of occupational safety information from multiple sources, including in vivo, in vitro toxicological studies, pre-clinical and clinical studies
• Excellent scientific and technical writing skills
• Self-motivated, able to work independently and prioritize tasks to meet timelines
• Works effectively with cross-functional teams across multiple sites and cultures

Other Requirements - preferred

• Experience with high-potency pharmaceutical handling techniques, pharmaceutical regulations and structure-activity relationships is advantageous.
• SDS and Label Authoring Registration

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