Director, Nonclinical Development - Respiratory, Topical and Transdermal
November 13
Description
• Serve as an active member for multi-disciplinary project teams as a nonclinical safety expert. • Articulate and communicate non-clinical safety strategies and provide development plans for multiple drug modalities. • Liaise with Non Clinical Operations and conduct nonclinical studies. • Participate in due diligence reviews of drug products and provide recommendations. • Author, review, and submit regulatory documents and interact with regulatory agencies. • Generate impurity, excipient, and metabolite risk assessments. • Review toxicological risk assessments and environmental risk assessments. • Support and mentor others regarding drug development.
Requirements
• Minimum of a master’s degree (or equivalent) and 10 years of experience. • Preferred candidates must possess an earned doctoral degree in Toxicology, Pharmacology or related field and 6 + years of experience in toxicology/pharmacology. • Must possess knowledge of the biological impact of drug product materials (APIs, excipients, impurities, etc.) in the human body. • Demonstrated knowledge of global regulatory requirements and expectations. • Effective oral and written communication, organizational and computer skills. • Proactive team player, excellent time management, problem-solving skills, and flexibility to work on multiple projects.
Benefits
• Competitive salaries • Inclusive environment
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