Principal Investigator-Nonclinical Safety Assessment (Office or Remote)

The Principal Investigator-Nonclinical Safety Assessment 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. Experience with authoring regulatory documents and preparations for health agency interactions preferred. Responsibilities:

• Work directly with the Nonclinical Safety team in life-cycle management of study activities which include study design, technical operations, protocol and reporting review, and assessment of toxicological risk in support of developmental programs indicated for cancer and inflammatory diseases.
• 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 and applying broad perspectives on relationship between different document types (eg. IB, IND modules, DSURs, IMPDs)
• Strong knowledge in toxicological assessment of pharmaceutical products, with regards to compliance to ICH and various regional guidances. Build strong understanding of other departments and their cross-dependencies with nonclinical safety.
• Active representative of the department to cross-functional teams, assisting with risk identification and risk assessment as needed. 

Qualifications:

• PhD with 8+ years or MS with 10+ years of experience in Toxicology, Pharmacology or a related scientific discipline in small molecule and/or biologics pharmaceutical drug development required.
• Experience at nonclinical CROs a plus.
• Working knowledge of GLP compliance and FDA/ ICH guidelines relevant to drug development required.
• Experience in preparing successful IND applications required.
• Experience in study direction or study monitoring of nonclinical studies required.
• 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.

This role can be based at our Hayward or location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $175,000- $200,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers.  EOEArcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets  PHYSICAL REQUIREMENTS: Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.