Director, Clinical Pharmacology
Arcus Biosciences
14 hours ago
Remote
United States
Clinical Research and Development
Director, Clinical Pharmacology (CP) — Role Overview:
- Serve as the Clinical Pharmacology (CP) team representative for small molecule and biotherapeutics in Phase 1–3 clinical development, supporting CP-related activities from study design through reporting and regulatory communication.
Essential Functions:
- In collaboration with CP leadership, design, conduct, analyze, interpret, and communicate results from CP studies.
- Perform hands-on analyses using noncompartmental methods, population PK/PD modeling and simulation, and exposure-response methodologies; communicate 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 partner lines to support smooth conduct of Ph I–III studies at study management team meetings.
- Contribute to key documents including 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; works under minimal supervision and communicates progress/delays.
- Anticipates issues with CPP deliverables and provides practical/innovative solutions.
- Demonstrates leadership in conflict navigation and resolution.
- Strong oral/written communicator; summarizes plans and analyses for cross-functional teams.
Education & Experience / Qualifications:
- Advanced degree in Pharmaceutics/Pharmacy/Engineering/Statistics with quantitative PK/PD expertise.
- Basic understanding of drug development and CP principles.
- Required: modeling/simulation software expertise (e.g., NONMEM, S-Plus/R).
- Highly desirable: other tools (e.g., GastroPlus, SimCYP, MATLAB, Berkeley-Madonna).
- Experience communicating effectively with cross-functional project teams.
- Good oral/written communication skills (publication track record).
Other Information:
- Occasional evening/weekend commitment.
- Occasional travel (~15%).
- Location: Hayward or Brisbane, CA (preferred) or remote.
- Serve as the Clinical Pharmacology (CP) team representative for small molecule and biotherapeutics in Phase 1–3 clinical development, supporting CP-related activities from study design through reporting and regulatory communication.
Essential Functions:
- In collaboration with CP leadership, design, conduct, analyze, interpret, and communicate results from CP studies.
- Perform hands-on analyses using noncompartmental methods, population PK/PD modeling and simulation, and exposure-response methodologies; communicate 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 partner lines to support smooth conduct of Ph I–III studies at study management team meetings.
- Contribute to key documents including 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; works under minimal supervision and communicates progress/delays.
- Anticipates issues with CPP deliverables and provides practical/innovative solutions.
- Demonstrates leadership in conflict navigation and resolution.
- Strong oral/written communicator; summarizes plans and analyses for cross-functional teams.
Education & Experience / Qualifications:
- Advanced degree in Pharmaceutics/Pharmacy/Engineering/Statistics with quantitative PK/PD expertise.
- Basic understanding of drug development and CP principles.
- Required: modeling/simulation software expertise (e.g., NONMEM, S-Plus/R).
- Highly desirable: other tools (e.g., GastroPlus, SimCYP, MATLAB, Berkeley-Madonna).
- Experience communicating effectively with cross-functional project teams.
- Good oral/written communication skills (publication track record).
Other Information:
- Occasional evening/weekend commitment.
- Occasional travel (~15%).
- Location: Hayward or Brisbane, CA (preferred) or remote.