Sr. Scientist - Non Clinical Safety

Location
Hayward, CA, United States
Posted
Jan 15, 2021
Ref
166
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
About Arcus Biosciences

Arcus is a clinical-stage, oncology-focused biopharmaceutical company creating best-in-class cancer therapies. With 4 compounds (2 antibodies and 2 small molecules) being evaluated across a dozen different clinical trials, Arcus is at the forefront of designing precision combinations in the pursuit of cures for patients living with cancer. Arcus also has a robust pipeline of preclinical and discovery programs that will continue to fuel the development pipeline and expected to enter the clinic in 2021.

Job Summary:

The Senior Scientist- Nonclinical Safety will function as a project toxicologist in providing scientific expertise in support of programs from discovery through both early and late phases of clinical development. Core responsibilities include oversight of IND-enabling toxicology studies at external CROs as Study Monitor, execution of studies within program timelines, and toxicology data interpretation and reporting.

Job Responsibilities:
  • Work directly with the Preclinical team in life-cycle management of nonclinical safety activities which include study design, technical operations, protocol and reporting review, and assessment of toxicological risk in support of developmental programs indicated for cancer.
  • Apply objectivity and interpret data in context with program goals.
  • An independent technical contributor with ability to manage multiple programs simultaneously.
  • Author regulatory documents to support global regulatory filings (e.g. IB, INDs)
  • Strong knowledge in toxicological assessment of pharmaceutical products, with understanding of other departments and their cross-dependencies.


Qualifications:
  • PhD in Toxicology, Pharmacology or a related scientific discipline with 5+ years in pharmaceutical drug development, nonclinical CRO, or both.
  • Experience in study direction or study monitoring of nonclinical studies required.
  • Working knowledge of GLP compliance and FDA/ ICH guidelines relevant to drug development required.
  • Small molecule and/or biologics development experience.
  • Demonstrated organizational, multi-tasking, and critical thinking skills.
  • Excellent written and oral communication internally and externally with CROs/ regulatory bodies.