Director, Nonclinical Safety Assessment

We are seeking exceptional talent to fill the role of Director of Nonclinical Safety Assessment, based in New York.

Responsibilities

• 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 Organizations (CROs) on study protocols, ongoing status of studies, monitor critical phases as needed, and review key findings from studies.
• Review toxicology study reports to generate quality reports for regulatory submissions.
• Identify and work with expert consultants depending on project specific needs.
• Effectively communicate with project teams, senior management, and regulatory agencies.
• Conduct due diligences and perform gap analyses on compounds for potential in-licensing opportunities.

Skills And Qualifications

• PhD or DVM preferred, or commensurate with experience, and 5-10 years of relevant industry experience.
• Board certification in toxicology (DABT) preferred
• Experience with gene therapies preferred.
• Excellent written, verbal, and interpersonal communication skills.
• Broad knowledge of pharmaceutical toxicology and its related disciplines and nonclinical drug development.
• Knowledge of drug development and life cycle management concepts and interdependencies with the overall development process.
• 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.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Matthew Tong at (+1) 6468786308 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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