Senior Scientist- Nonclinical Safety

Location
Hayward, California
Posted
Oct 21, 2021
Ref
oXyihfwO
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time

Locations: Hayward, California | Brisbane, California | Remote, United States

Senior Scientist- Nonclinical Safety
Reports to: Director, Preclinical Development
Location: Hayward, CA or SF/Brisbane, CA or remote

About Arcus Biosciences
Arcus is a clinical-stage, oncology-focused biopharmaceutical company creating best-in-class cancer therapies. With 5 compounds (3 antibodies and 2 small molecules) being evaluated across over 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 with 5+ years or MS with 8+ years of experience in Toxicology, Pharmacology or a related scientific discipline 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 a plus.
• Knowledge of analytical method development and validation for small molecules or biologics a plus.
• Demonstrated organizational, multi-tasking, and critical thinking skills.
• Excellent written and oral communication internally and externally with CROs/ regulatory bodies.

Arcus is an equal opportunity employer.