Serve as the Clinical Pharmacology representative on project teams for small molecule and biotherapeutic agents during Phase 1-3 clinical development
Provide support for all clinical pharmacology-related tasks
Plan and carry out clinical pharmacology studies
Design the clinical pharmacology components of other clinical trials
Conduct hands-on data analysis and reporting
Communicate data and analysis findings in regulatory submissions and meetings
Collaborate with Clinical Pharmacology leadership to design, execute, analyze, interpret, and present results from Clinical Pharmacology studies under guidance
Perform hands-on analyses using noncompartmental methods, population PKPD modeling and simulation, and exposure-response techniques; share risk/benefit insights with Clinical Pharmacology and project teams
Work with Clinical Pharmacology leadership to create short- and medium-term project plans from IND to NDA/BLA stages
Present these strategies during internal meetings
Cooperate and communicate with partner functions to ensure smooth execution of Phase I-III studies at study management team meetings
Assist in preparing key documents such as investigators brochures, clinical study protocols, study reports, and regulatory briefing documents
Help establish best practices for Clinical Pharmacology activities, including drafting department SOPs, setting up quality systems, and creating plan/report templates

Advanced degree in Pharmaceutics, Pharmacy, Engineering, or Statistics with proven quantitative PKPD skills
Fundamental knowledge of drug development and Clinical Pharmacology principles
Proficiency with standard modeling and simulation software like NONMEM and S-Plus/R
Experience in active and effective communication within cross-functional project teams
Strong oral and written communication abilities, evidenced by a publication history

Expertise in additional modeling software such as GastroPlus, SimCYP, MATLAB, or Berkeley-Madonna

Hybrid — Hayward, CA, Brisbane, CA

Occasional evening and/or weekend work may be required
Occasional travel, approximately 15%, both domestic and international
Role can be based in Hayward or Brisbane, CA (preferred) or remote
Must have mobility to work in a standard office environment and use standard office equipment, including a computer
Vision sufficient to read printed materials and a computer screen
Hearing and speech adequate for in-person communication, group presentations, and telephone conversations
Primarily sedentary office work, though standing in work areas and walking between areas may be necessary
Finger dexterity needed to operate a computer keyboard, mouse, calculator, and standard office equipment
Occasional bending, stooping, kneeling, reaching, pushing, and pulling drawers to retrieve and file information
Ability to lift, carry, push, and pull objects weighing up to 25 pounds

Arcus Biosciences is hiring a Director, Clinical Pharmacology