Responsibilities:
- 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 plans for projects across clinical development (IND to NDA/BLA) and communicate strategies internally.
- Collaborate and communicate with partner teams to support smooth Phase IโIII study conduct.
- Contribute to preparation of key documents (investigatorsโ 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; self-monitors progress and communicates delays.
- Anticipates problems with CP deliverables; demonstrates practical, innovative problem-solving.
- Demonstrates leadership courage in conflict navigation and resolution.
- Strong oral and written communication; summarizes clinical pharmacology plans and analyses for cross-functional teams.
Qualifications:
- Advanced degree in Pharmaceutics/Pharmacy/Engineering/Statistics with demonstrated expertise in quantitative PK/PD.
- Basic understanding of drug development and CP principles.
- Required: modeling and simulation software expertise (NONMEM, S-Plus/R, etc.).
- Highly desirable: other modeling software (e.g., GastroPlus, SimCYP, MATLAB, Berkeley-Madonna).
- Experience communicating effectively with cross-functional project teams.
- Strong oral/written communication demonstrated by publication track record.
Other Information:
- May require occasional evening/weekend commitment.
- May require occasional travel (~15%) domestic and international.
- Based in Hayward or Brisbane, CA (preferred) or remote.