Director/Senior Director, Nonclinical SafetyThis role will lead the safety strategy, through both preclinical and clinical stages, and direct all phases of in vivo GLP and non-GLP toxicology studies, in collaboration with study teams, CROs and consultants. The person in this role will interface with various functional groups within the company and will report to our ED/VP of Nonclinical Safety.
In this role, you will:
- Develop the strategic nonclinical toxicology development plan for programs in development in collaboration with stakeholders
- Collaborate with CMC, Program & Portfolio Management, Clinical, Medical, and Regulatory Affairs to develop program-specific strategies for appropriate data generation in support of development candidate nomination, IND/CTA filing, and clinical development of new small molecule drug entities
- Represent Nonclinical Safety at cross-functional project teams
- Oversee the design and execution of safety pharmacology and toxicology studies (GLP and non-GLP) supporting preclinical and clinical development programs consistent with company timelines and goals
- Contribute to the selection and management of consultants and CROs to support nonclinical safety studies for development programs
- Manage nonclinical safety studies conducted by CROs with efficient governance including contract execution, authorization of study amendments, schedule and budget variance management, progress reporting to stakeholders, review of data and draft study reports, completion of contract milestones, study close-out and alignment of nonclinical safety evaluations with drug development efforts and priorities
- Ensures completion of nonclinical safety studies to support Company timelines and goals
- Respond to questions and prepare discussions documents for the FDA to in support of development programs.
- Ensure compliance with global nonclinical toxicology and safety studies as per regulatory guidelines
These Qualifications Will Help This Role Be Successful
- PhD in Toxicology/Pathology or DVM and approximately 10 years of toxicology experience in the pharmaceutical industry or Master's in Toxicology/Pathology or DVM and approximately 15 years of experience
- Experience in nonclinical GLP toxicology and safety assessment of small molecules from discovery through regulatory submission
- Strong leadership competencies and management experience, including selecting CROs and overseeing the quality of relationships
- Demonstrated knowledge and full understanding of GLP regulatory requirements and providing responses to the FDA
- DABT certification is preferred, but not required
- Attention to detail quality and compliance
- Excellent verbal and written communication and organizational skills required with demonstrated success in leading projects and interacting with cross functional teams
- Ability to navigate, problem-solve, execute, and lead in a dynamic, fast-paced and evolving environment
Base salary range: $225,000 - $285,000
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