What are the responsibilities and job description for the The Head of Toxicology position at Gan & Lee Pharmaceuticals?
Job Description:
The Head of Toxicology is responsible for developing the strategy for 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:
Qualifications:
The Head of Toxicology is responsible for developing the strategy for 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 toxicology assessment strategies, design and oversee nonclinical toxicology studies, review and finalize protocols and reports, and manage the studies with collaborators and CROs as needed.
- Analyze, interpret, and summarize 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.
- 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 toxicology or related fields. DABT strongly preferred.
- At least 8 years of experience in 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.
