Director, Clinical Pharmacology
Arcus Biosciences
18 days ago
Remote
United States
Clinical Research and Development
Director, Clinical Pharmacology (CP)
Role 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 PK/PD modeling and simulation, and exposure-response methodologies; disseminate risk/benefit implications to CP and project teams.
- Develop short/medium-term project plans across clinical development (IND to NDA/BLA) and communicate strategy at internal meetings.
- Collaborate with study management and partner lines to support smooth conduct of Phase I–III studies.
- Contribute to preparation of investigators’ brochures, clinical study protocols, study reports, and regulatory briefing documents.
- Help establish best practices for CP activities (e.g., draft SOPs, establish quality systems, create plan/report templates).
Key Competencies/Behaviors:
- Independent, self-motivated, self-starter working with minimal supervision.
- Problem-solving skills; anticipates issues with CPP deliverables.
- Demonstrates leadership and effective conflict navigation/resolution.
- Strong oral and written communicator; summarizes CP plans and analyses to cross-functional teams.
Qualifications:
- Advanced degree in Pharmaceutics/Pharmacy/Engineering/Statistics with demonstrated quantitative PK/PD expertise.
- Basic understanding of drug development and CP principles.
- Required: expertise with modeling/simulation software (NONMEM, S-Plus/R, etc.).
- Preferred: experience with other tools (e.g., GastroPlus, SimCYP, MATLAB, Berkeley-Madonna).
- Experience communicating effectively with cross-functional project teams.
- Good oral/written communication skills demonstrated by publication track record.
Other Information:
- May require occasional evening/weekend work and ~15% domestic/international travel.
- Location: Hayward or Brisbane, CA (preferred) or remote.
Role 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 PK/PD modeling and simulation, and exposure-response methodologies; disseminate risk/benefit implications to CP and project teams.
- Develop short/medium-term project plans across clinical development (IND to NDA/BLA) and communicate strategy at internal meetings.
- Collaborate with study management and partner lines to support smooth conduct of Phase I–III studies.
- Contribute to preparation of investigators’ brochures, clinical study protocols, study reports, and regulatory briefing documents.
- Help establish best practices for CP activities (e.g., draft SOPs, establish quality systems, create plan/report templates).
Key Competencies/Behaviors:
- Independent, self-motivated, self-starter working with minimal supervision.
- Problem-solving skills; anticipates issues with CPP deliverables.
- Demonstrates leadership and effective conflict navigation/resolution.
- Strong oral and written communicator; summarizes CP plans and analyses to cross-functional teams.
Qualifications:
- Advanced degree in Pharmaceutics/Pharmacy/Engineering/Statistics with demonstrated quantitative PK/PD expertise.
- Basic understanding of drug development and CP principles.
- Required: expertise with modeling/simulation software (NONMEM, S-Plus/R, etc.).
- Preferred: experience with other tools (e.g., GastroPlus, SimCYP, MATLAB, Berkeley-Madonna).
- Experience communicating effectively with cross-functional project teams.
- Good oral/written communication skills demonstrated by publication track record.
Other Information:
- May require occasional evening/weekend work and ~15% domestic/international travel.
- Location: Hayward or Brisbane, CA (preferred) or remote.