Director, Clinical Pharmacology

Arcus Biosciences•Brisbane, CA

19h•Remote

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.