Director, Nonclinical Safety Assessment
This vacancy has now expired. Please see similar roles below...
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.
#LI-91653573_MT1
Related jobs
Highly Competitive Salary
Bristol, USA
Proclinical is seeking a Facilities Engineer to join our client's team. This is a permanent position located in Bristol, PA.
Highly Competitive Salary
Philadelphia, USA
Proclinical is seeking a dedicated and detail-oriented QC Analyst, Microbiology. This is a contract position located in Philadelphia, PA.
Highly Competitive
Paris, France
Proclinical is seeking a dedicated and strategic individual for the role of Associate Director, Field Business Lead.
Highly Competitive Salary
Cambridge, USA
Proclinical is seeking a dedicated QC Microbiologist to support our vaccine manufacturing site. This is a contract position located in Cambridge, MA.
Highly Competitive Salary
München (81249), Deutschland
Proclinical sucht einen engagierten regionalen Vertriebsleiter für die Osthälfte Deutschlands im Bereich Urologie.
Highly Competitive
Deutschland
Proclinical are currently in search of a dynamic Statistical Project Leader.
Highly Competitive
Tuttlingen, Germany
Proclinical sucht einen Systems Engineer - Instruments für einen Kunden aus der Medizintechnik-Branche.
Highly Competitive
Singapore River, Singapore
Proclinical are recruiting for a Senior eCommerce Manager APAC (6 months maternity cover) to join a pharmaceutical organisation.
Highly Competitive
Tuttlingen (78532), Deutschland
Proclinical auf der Suche nach einem Systems Engineer (m/w/d).
Highly Competitive
Singapore
Proclinical is seeking a dedicated Automation Engineer to provide technical support for smooth manufacturing operations.