[Hiring] Director, Clinical Pharmacology @Arcus Biosciences

Role Description

At Arcus, the Director, Clinical Pharmacology (CP) functions as the Clinical Pharmacology (CP) team representative at the project teams for small molecule and biotherapeutics in Phase 1-3 of clinical development and is responsible for supporting all clinical pharmacology-related activities. This includes:

• Design and execution of clinical pharmacology studies
• Design of clinical pharmacology portion of other clinical studies
• Hands-on analysis and reporting of data
• Communication of data and analysis reports in regulatory documents and meetings

This position will report into one of the Senior/Executive Directors within the department of Clinical Pharmacology and Pharmacometrics. Most activities will be conducted under the supervision of the Manager.

Qualifications

• An advanced degree in Pharmaceutics/Pharmacy/Engineering/Statistics with demonstrated expertise in quantitative PKPD skills
• Basic understanding of drug development and CP principles
• Expertise with standard modelling and simulation software (NONMEM, S-Plus/R, etc.) is required
• Expertise in other modelling software (e.g. GastroPlus, SimCYP, MATLAB, Berkeley-Madonna, etc.) is highly desirable
• Experience of active and effective communication with cross-functional project teams
• Good oral and written communication skills as shown by a publication track record

Requirements

• In collaboration with CP leadership, design, conduct, analyze, interpret, and communicate results from CP studies with guidance
• Perform hands-on analyses of data using noncompartmental methods, population PKPD modeling and simulation, and exposure-response methodologies; disseminate the relevant risk/benefit implications to CP and project teams
• Develop short/medium-term plans for projects at all stages of clinical development - IND to NDA/BLA
• Collaborate and communicate with partner lines for smooth conduct of Ph I-III studies at study management team meetings
• Contribute to the preparation of key documents including investigators brochures, clinical study protocols, study reports, and regulatory briefing documents
• Contribute to the establishment of best practices for CP activities – e.g. draft department SOPs, establish quality systems, create plan/report templates, etc.

Benefits

• Competitive market-based salary
• Opportunity to participate in stock programs
• Performance-based bonus
• Comprehensive benefits package

Other Information

• Position may require occasional evening and/or weekend commitment
• Position may require occasional travel (~15%), domestic and international
• This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based
• The anticipated salary range for fully qualified candidates applying for this position is $245,000 - $260,000 USD annually