Director, Clinical Pharmacology

Arcus Biosciences•Hayward, CA

6d•$245,000 - $260,000•Hybrid

About The Position

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, and 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.

Requirements

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.
Experience of active and effective communication with cross-functional project teams.
Good oral and written communication skills as shown by a publication track record

Nice To Haves

Expertise in other modelling software (e.g. GastroPlus, SimCYP, MATLAB, Berkeley-Madonna, etc.) is highly desirable.

Responsibilities

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.
In collaboration with CP leadership, develop short/medium-term plans for projects at all stages of clinical development - IND to NDA/BLA. Communicate these strategies at internal meetings
Collaborate and communicate with partner lines at 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.
As a lean but growing department, contribute to the establishment of best practices for CP activities – e.g. draft department SOPs, establish quality systems, create plan/report templates, etc.