Scientist

Location
92121, San Diego
Posted
Jan 29, 2019
Required Education
Doctorate/PHD/MD
Position Type
Full time

We are seeking an experienced highly motivated Toxicologist to join a growing and dynamic development team. This individual will be an integral part of the company‚Äôs efforts to discover and develop small molecule therapeutics for rare disorders and cancers. 

Responsibilities:

  • Responsible for the day-to-day operational activities for outsourced non-GLP and GLP toxicology and safety pharmacology studies. Specific tasks include: 
  • Directly interface with contract research organizations (CROs) to request quotes and derive cost estimates, schedule and place studies, and oversee the generation and approval of contracts and subsequent invoicing 
  • Review nonclinical study proposals and ensure that they fulfill all requirements of the program development plan 
  • Assist in the preparation, review, and/or finalization of study protocol and reports 
  • Coordinate shipping/receipt of test article and study-related samples to appropriate CROs 
  • Manage study updates, data and documents, and track and maintain study specific milestones 
  • Assist in the development and management of timelines 
  • Assist in monitoring exploratory and GLP toxicity studies (in vitro and in vivo) required for lead optimization, development candidate selection and support of regulatory filings 
  • Communicate toxicity study results to cross-functional program teams and to the management, as needed 
  • Assist in the writing of regulatory submissions (INDs, DSURs, IBs, and NDAs) 
  • Perform QC on Toxicology and Safety Pharmacology documents 
  • Maintain a current understanding of toxicology literature, methodology, and regulatory requirements 

Requirements:

  • PhD or MS in toxicology or related discipline with at least 3 years of related experience, or BS in biological sciences with at least 5 years of related experience 
  • Previous industry experience in a Biotech, Pharma or CROs preferred 
  • Experience in designing, monitoring, and interpreting nonGLP and GLP toxicity studies
  • Strong communication (written and oral) and interpersonal skills with an ability to effectively function within a matrixed environment 
  • Familiarity with FDA, EMA, and ICH guidance documents 
  • Excellent organizational skills required 
  • Excellent writing skills as they relate to the preparation of reports and regulatory documents 
  • Excellent critical problem-solving ability