Director, Nonclinical Safety Assessment
Cartwright James is currently representing a leading Gene Therapy company. They are currently seeking a Director, Nonclinical Safety Assessment, to be based out of their East Coast US office.
Reporting directly to the Sr. Director of Pharmacology, the successful candidate would be responsible for managing the nonclinical safety of potential compounds in various stages of development.
Key responsibilities include:
- Generate safety assessment development plans for compounds in the portfolio
- Serve as a toxicology representative on assigned program teams, author nonclinical safety risk assessment documents for clinical programs and regulatory submissions
- Work closely with Contract Research Organisations (CROs) on study protocols, ongoing status of studies, monitor critical phases as needed, and review key findings from studies
- Identify and work with expert consultants depending on project specific needs
- Conduct due diligence and perform gap analyses on compounds for potential in-licensing opportunities.
- PhD or DVM preferred, or MS with equivalent experience
- Board certification in toxicology (DABT) preferred
- Experience with gene therapies preferred
- 5-10 years pharmaceutical, with knowledge and experience in aspects of drug development
- Broad knowledge of pharmaceutical toxicology and its related disciplines and nonclinical drug development
- Experience as a nonclinical safety assessment project team member on a drug development team
- Experience writing the nonclinical safety assessment portions of an IND/CTA and IB
- Proven ability to manage multiple projects/tasks at one time
Cartwright James is a global executive search and selection company based in the UK, providing expert knowledge and bespoke services in the international Chemicals, Medical and Scientific markets. We receive a vast volume of applications for each position, therefore it takes time to assess each candidate. We will be in touch if the candidates experience matches the job requirements.
Job Reference: CJ-SCI-DNCS