Director/Senior Director Toxicology

Job Summary:

As a Director/Senior Director of Toxicology, you will play a critical role in ensuring the safety and efficacy of our pharmaceutical biologics. You'll lead and oversee toxicology programs, from target identification to GLP (Good Laboratory Practice) toxicity studies, supporting clinical development and eventual market approval. Your expertise will be essential in identifying safety issues, collaborating with regulatory experts, and communicating crucial results to project teams and company leadership. This position reports to the Executive Director of Safety.

Primary Responsibilities:

• Organize and manage toxicology programs strategically, ensuring alignment with clinical development goals and regulatory requirements.

• Conduct safety evaluations on treatment targets during early stages to proactively detect potential safety concerns.

• Develop mitigation strategies to address safety issues.

• Work closely with regulatory experts to facilitate the smooth transition of biologics into development and First-in-Human (FIH) trials.

• Collaborate with scientific leadership, strategic outsourcing partners, and consultants to design and implement investigative toxicology studies.

• Support research and development efforts through well-designed toxicology studies.

• Ensure the accuracy, validity, and completeness of scientific information in non-GLP and GLP non-clinical research.

• Prepare regulatory documentation related to toxicology studies (e.g., IND, IB, BLA, submissions).

• Communicate critical results, interpretations, and project information to various stakeholders, including project teams and company leadership.

• Manage nonclinical Contract Research Organizations (CROs) for specific programs.

Qualifications:

• PhD or DVM with 10+ years of toxicology experience in the pharmaceutical industry or Master's in Toxicology with 15+ years of experience.

• Certification (Desirable): DABT certification or veterinary degree with pathology training.

• Industry Knowledge: Familiarity with pharmaceutical toxicology and regulatory processes.

• Expertise in either Biologics-related toxicology or developmental and reproductive (DART)-related toxicology.

• Collaborative Approach: Demonstrated ability to collaborate effectively in a team environment.

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