Director, Clinical Pharmacology
Arcus Biosciences
18 days ago
Remote friendly (United States)
United States
Clinical Research and Development
Director, Clinical Pharmacology (CP)
Responsibilities:
- In collaboration with CP leadership, design, conduct, analyze, interpret, and communicate results from CP studies.
- Perform hands-on data analyses using noncompartmental methods, population PKPD modeling and simulation, and exposure-response methodologies; disseminate 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) and communicate strategies at internal meetings.
- Collaborate with study management and partner lines to support smooth conduct of Ph I–III studies.
- Contribute to preparation of key documents: investigators’ brochures, clinical study protocols, study reports, and regulatory briefing documents.
- Help establish best practices for CP activities (e.g., draft CP SOPs, establish quality systems, create plan/report templates).
Key Competencies/Behaviors:
- Independent, self-motivated; works with minimal supervision; monitors progress and communicates delays.
- Anticipates and solves problems related to CPP deliverables.
- Demonstrates leadership through conflict navigation and resolution.
- Strong oral and written communicator; summarizes clinical pharmacology plans and analyses to cross-functional teams.
Qualifications/Requirements:
- Advanced degree in Pharmaceutics/Pharmacy/Engineering/Statistics with demonstrated quantitative PKPD expertise.
- Basic understanding of drug development and CP principles.
- Expertise with modeling/simulation software (NONMEM, S-Plus/R, etc.) required; GastroPlus, SimCYP, MATLAB, Berkeley-Madonna highly desirable.
- Experience communicating effectively with cross-functional project teams.
- Strong oral and written communication skills demonstrated by a publication track record.
Other Information:
- Occasional evening/weekend commitment.
- Occasional travel (~15%), domestic and international.
Location:
- Hayward or Brisbane, CA (preferred) or remote based.
Responsibilities:
- In collaboration with CP leadership, design, conduct, analyze, interpret, and communicate results from CP studies.
- Perform hands-on data analyses using noncompartmental methods, population PKPD modeling and simulation, and exposure-response methodologies; disseminate 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) and communicate strategies at internal meetings.
- Collaborate with study management and partner lines to support smooth conduct of Ph I–III studies.
- Contribute to preparation of key documents: investigators’ brochures, clinical study protocols, study reports, and regulatory briefing documents.
- Help establish best practices for CP activities (e.g., draft CP SOPs, establish quality systems, create plan/report templates).
Key Competencies/Behaviors:
- Independent, self-motivated; works with minimal supervision; monitors progress and communicates delays.
- Anticipates and solves problems related to CPP deliverables.
- Demonstrates leadership through conflict navigation and resolution.
- Strong oral and written communicator; summarizes clinical pharmacology plans and analyses to cross-functional teams.
Qualifications/Requirements:
- Advanced degree in Pharmaceutics/Pharmacy/Engineering/Statistics with demonstrated quantitative PKPD expertise.
- Basic understanding of drug development and CP principles.
- Expertise with modeling/simulation software (NONMEM, S-Plus/R, etc.) required; GastroPlus, SimCYP, MATLAB, Berkeley-Madonna highly desirable.
- Experience communicating effectively with cross-functional project teams.
- Strong oral and written communication skills demonstrated by a publication track record.
Other Information:
- Occasional evening/weekend commitment.
- Occasional travel (~15%), domestic and international.
Location:
- Hayward or Brisbane, CA (preferred) or remote based.