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Director of Toxicology and Regulatory Affairs
2 months ago
We are seeking an experienced Executive Director, Toxicology to join our team at International Staff Consulting. This is a key leadership role that will oversee the activities of our Toxicology group and provide strategic direction to ensure the successful execution of toxicology studies.
Key Responsibilities- Provide leadership and oversight to the Toxicology function, ensuring that all nonclinical safety assessments are conducted in accordance with regulatory guidelines and company standards.
- Develop and implement strategic plans to drive the growth and development of the Toxicology function, including the preparation of safety pharmacology and toxicology sections of regulatory documents.
- Collaborate with cross-functional teams, including Research and Development, to ensure the provision of safety pharmacology and toxicology support to meet development goals.
- Critically evaluate toxicology results and provide timely strategic advice to project teams and senior management on the potential impact of toxicology results on program and clinical/regulatory strategy.
- Represent Preclinical Development on discovery and development-stage program teams and develop critical insights from data summaries to shape presentations of results to peers, colleagues, and company management.
- Oversee the adherence to all SOPs for Toxicology and proactively research and stay current on all applicable regulatory guidances.
- PhD in Toxicology, Pathology, or a closely related discipline, or D.V.M. with 8+ years of similar experience.
- 12+ years of pharmaceutical/biotech experience, including managing clinical Contract Research Organizations, with experience in toxicologic pathology being beneficial.
- Extensive knowledge of toxicologic pathology, managing clinical Contract Research Organizations, and preparing regulatory documents, including INDs, CTAs, NDAs, and MAAs.
- Excellent interpersonal and communication skills, with the ability to interact professionally and effectively with peers, management, and leadership both within and outside the company.
- Demonstrated ability to influence and lead others, with a strong track record of career development and mentoring direct and indirect reports.
As an Executive Director, Toxicology at International Staff Consulting, you will have the opportunity to work with a talented team of professionals and contribute to the success of our company. We offer a competitive compensation package, including a robust relocation package and other long-term incentives.
