Job Description

Job Description:
The Head of Pharmacology and Toxicology is responsible for developing the strategy for pharmacology and toxicology studies of new drugs, leading safety assessments, and ensuring that safety evaluations comply with international standards. This role involves collaborating with cross-functional teams and CROs to integrate toxicology findings into development strategies.  
Key Responsibilities:

• Provide pharmacology and toxicology assessment strategies, design and oversee nonclinical toxicology and safety pharmacology studies, review and finalize protocols and reports, and manage the studies with collaborators and CROs as needed.
• Analyze, interpret, and summarize nonclinical safety and toxicology data and present data to internal project teams and leadership while providing strategic guidance and interpretation.
• Author and review nonclinical sections for all regulatory filings including IND, CTA, BLA, NDA, IB, etc, with a focus on toxicology and pharmacology.
• Lead the evaluation and selection of CROs and act as the main point of contact for non-clinical research communication while continuously tracking study progress to assess the performance of CROs.
• Mentor junior team members and contribute to the long-term vision for the Nonclinical team.
• Collaborate closely with clinical development teams, integrating toxicology data into strategic decisions.
• Represent preclinical studies on project teams and interface with internal stakeholders, as well as with external stakeholders and regulatory agencies.

Qualifications:

• PhD in pharmacology, toxicology, pharmacokinetics, pharmacodynamics, or related fields. DABT strongly preferred.
• At least 8 years of experience in pharmacology and toxicology research and management in pharmaceuticals, biotechs, and CROs.
• Proven expertise in toxicology study design, execution, and related regulatory strategies.
• Excellent communication and team management skills, with the ability to coordinate cross-departmental resources.
• Experience in team management and CRO management.

Job Tags

Full time,

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