DescriptionAt 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.
Essential Functions:
- 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.
Key competencies/behaviors:- Independent worker, self-motivated and self-starter. Works under minimal supervision on all activities. Self monitors progress, recognizes delays, and communicates appropriately
- Anticipates problems in the execution of CPP deliverables, displays problem-solving skills to come up with practical and innovative solutions
- Demonstrates leadership courage through effective conflict navigation and resolution.
- Strong oral and written communicator; able to summarize clin pharm plans and analyses to cross-functional teams
Education & Experience: - 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. Expertise in other modelling software (e.g. GastroPlus, SimCYP, MATLAB, Berkeley-Madonna, etc.) is highly desirable.
- Experience of active and effective communication with cross-functional project teams.
- Good oral and written communication skills as shown by a publication track record
Other Information - Position may require occasional evening and/or weekend commitment
- Position may require occasional travel (~15%), domestic and international.
This role can be based at our Hayward or Brisbane, CA location (preferred) or can be remote based. The anticipated salary range for fully qualified candidates applying for this position is $245,000 - $260,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here: https://arcusbio.com/careers.
#LI-Remote
#LI-JS1
