Manager of Toxicoloty

Location
San Diego, California
Posted
Feb 21, 2018
Ref
Toxicology
Required Education
Doctorate/PHD/MD
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

  • Design, conduct and/or monitor, and interpret exploratory toxicity studies (in vitro and in vivo) required for lead optimization, and development candidate selection
  • Plan, budget, design, monitor, and interpret regulatory toxicity studies (in vitro and in vivo) required for IND and NDA submissions, including general toxicity, genotoxicity, safety pharmacology, reproductive and developmental, and carcinogenicity studies
  • Prepare RFPs, review budgets, and select vendors
  • Qualify nonclinical toxicology vendors based on performance, compliance and regulatory inspection history
  • Assist in the development and management of timelines.
  • Work with experts in the field of toxicology (eg, consultants) to interpret study results and make recommendations
  • Communicate toxicity study results to cross functional program teams and to the management, as needed
  • Directly interface with contract research organizations (CROs) to request quotes and derive cost estimates, provide input during protocol development and report generation/finalization and monitor study activities
  • Review nonclinical study proposals and ensure that they fulfill all requirements of the program development plan
  • Assist in the writing of regulatory submissions (INDs, DSURs, IBs, and NDAs)
  • Maintain a current understanding of toxicology literature, methodology and regulatory requirements
  • Other tasks as assigned

Minimum Qualifications

  • PhD in toxicology or related discipline with at least 5 years of related experience, or BS in biological sciences with at least 10 years of related experience
  • Previous industry experience in a biotech or pharma company 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 (national and international) may be required up to 15% of your time