South San Francisco
£180k - 250k per year + Extensive benefits package
about 2 months ago
My client, a growing global biopharmaceutical company with a broad portfolio focussed on antiviral, metabolic and liver, cancer and inflammation therapeutic areas, is looking for a Toxicology Director to be responsible for managing nonclinical safety development programs, working with other members of the department regarding strategy for nonclinical safety programs. A strong background in Regulatory Toxicology including extensive knowledge and understanding of Good Laboratory Practices (GLPs), ICH Guidelines, experience interacting with Regulatory Authorities, and authorship of Regulatory Correspondences and Dossiers is required.
- You will play a key role on cross functional teams – including R&D Teams, where you will be responsible for the design, implementation, oversight and analysis of nonclinical programs to support drug development candidates across a variety of platforms.
- Actively supports the integration of early nonclinical safety strategies throughout Research.
- Plan, design, and effectively manage/conduct and oversee designated toxicology programs necessary to support the selection and timely development of potential drug candidates through close interactions with discovery toxicologists, and affiliated preclinical and clinical development functions, as necessary
- Coordinate preclinical safety evaluations locally and internationally with CROs and other external parters
- Potential to lead Non-Clinical Development sub-teams.
- Responsible for relevant regulatory documents (IBs, BLAs, INDs, NDAs, Expert Reports, etc.)
- Ph.D. in Toxicology or relevant field; DABT Board certification preferred.
- A minimum of 6-12 years of experience in industry with a proven track record of conduct of drug safety assessment studies, demonstrated ability to manage personnel and multiple scientific projects, and make sound scientific interpretations and risk assessments
- Proficient knowledge of general toxicology is required
- Highly proficient in understanding and knowledge of regulatory toxicology
- Strong problem solver who is highly organized with the ability to thrive and to lead in an environment with rapidly changing priorities