Scientist Toxicology

Location
San Diego, California
Posted
Aug 23, 2018
Ref
Toxicology
Required Education
Masters Degree/MBA
Position Type
Full time

Crinetics Pharmaceuticals is seeking an experienced highly motivated Toxicologist to join its growing and dynamic development team. This individual will be an integral part of the company’s efforts to discover and develop small molecule therapeutics for rare endocrine disorders and endocrine-related cancers. This is a unique opportunity to work with a proven and well-funded drug discovery and development team in a small company environment in the heart of San Diego’s biotechnology community.

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
  • Other tasks as assigned

Minimum Qualifications

  • 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 company 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 of FDA, EMA, and ICH guidance documents
  • Excellent organizational skills required
  • Excellent writing skills as they relate to preparation of reports and regulatory documents
  • Excellent critical problem-solving ability

Travel

Travel (domestic and international) may be required up to 10% of your time