Toxicologist job

Organization
Spark Therapeutics
Job Location
Philadelphia, PA
Job Description

We are looking for an experienced toxicologist scientist with the passion and creativity to develop AAV-based therapies. A person in this position is responsible for the preparation of pharmacology and toxicology components of regulatory submissions for all clinical study programs in support of IND and BLA packages and responding to inquiries from regulatory authorities. The ideal candidate will have experience in evaluating and addressing global pharmacology and toxicology issues. 

This person will provide the execution of the strategy for generating the toxicology data required to support all phases of global development including: studies to support drug candidate optimization and selection, generation of toxicology data packages to support regulatory submissions as well as the data required to understand the performance of products in the clinical setting. 

RESPONSIBILITIES: 

Responsible for draft, edit and finalization of nonclinical study and technical reports and nonclinical sections for IND and BLA submissions, as well as required reports for maintenance of applications to ensure regulatory compliance 
Participate in discussions with FDA to obtain feedback and respond to inquiries related to nonclinical development 
Critically review and edit CRO toxicology study reports, analyze and interpret data and coordinate report finalization 
Design and manage nonclinical studies (GLP and non-GLP) for inclusion in regulatory submissions, including pharmacology, pharmacokinetics and toxicology studies 
Direct internal toxicology and pharmacology studies 
Provide data analysis and interpretation in preparation for final reports 
Ensure regulatory submission and compliance 
Maintain a current understanding of toxicology literature and methodology, as well as the scientific literature related to the specific drug discovery projects 
Perform quality control checks on non-clinical pharmacology and toxicology documents for regulatory submission

Requirements: 

QUALIFICATIONS: 

Self-starter with excellent management capabilities who is seeking to be part of an innovative team to support the company’s drug development process 
Experience in histopathology and some hands-on laboratory experience is desired 
Ability to synthesize and interpret diverse, multidisciplinary data sets 
REQUIREMENTS: 

Ph.D. in toxicology or biological sciences 
Minimum of 5 years of industry experience in toxicology and the development of biologics 
Required experience in preparing INDs (BLA/NDAs, a plus) 
Experience responding to regulatory questions related to pharmacology, pharmacokinetics and toxicology 
Understanding of CMC, QA, regulatory and clinical functions to guide nonclinical activities setting up products for success at all stages of development 
Experience with gene-based and/or protein-based products for metabolic and genetic disease targets 
Experience in establishing and managing external CROs with timely delivery of clear and accurate well-written study findings 
Experience in designing and interpreting nonclinical safety studies 
Strong knowledge of pre-clinical drug development and FDA and ICH guidance documents including GLP regulations for nonclinical studies with biologics is essential 
Experience evaluating the pharmacokinetic properties of biologics is a plus

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