Description
At Arcus, the Director, Clinical Pharmacology (CP) serves as the CP team representative on project teams for small‐molecule and biotherapeutic studies in Phase 1‐3. The role supports all clinical pharmacology‐related activities, including design and execution of CP studies, integration of the CP component into other studies, hands‐on analysis and reporting of data, and communication of results in regulatory documents and meetings. The position reports to a Senior/Executive Director in the Clinical Pharmacology and Pharmacometrics department and is largely supervised by the Manager.
Essential Functions
* Design, conduct, analyze, interpret, and communicate results from CP studies with guidance from CP leadership.
* Perform hands‐on analyses using non‐compartmental methods, population PKPD modeling and simulation, and exposure‐response methodologies; disseminate risk/benefit implications to CP and project teams.
* Develop short‐ and medium‐term plans for projects across all stages of clinical development (IND to NDA/BLA) and communicate these strategies at internal meetings.
* Collaborate with partner lines to ensure smooth conduct of Phase I‐III studies at study management team meetings.
* Contribute to key documents, including investigator brochures, clinical study protocols, study reports, and regulatory briefing documents.
* Help establish best practices for CP activities—draft department SOPs, establish quality systems, and create plan/report templates.
Key Competencies/Behaviors
* Independent worker, self‐motivated and self‐starter; works under minimal supervision, self‐monitors progress, recognizes delays, and communicates appropriately.
* Anticipates problems in delivering CP deliverables and demonstrates problem‐solving skills to develop practical, innovative solutions.
* Shows leadership courage through effective conflict navigation and resolution.
* Strong oral and written communication skills; able to summarize clinical pharmacology plans and analyses to cross‐functional teams.
Education & Experience
* Advanced degree in Pharmaceutics, Pharmacy, Engineering, or Statistics with demonstrated expertise in quantitative PKPD skills.
* Basic understanding of drug development and CP principles.
* Expertise with standard modeling and simulation software (NONMEM, S‐Plus/R, etc.) required; additional expertise in GastroPlus, SimCYP, MATLAB, Berkeley‐Madonna, or similar highly desirable.
* Experience communicating actively and effectively with cross‐functional project teams.
* Good oral and written communication skills as evidenced 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.
Compensation and Benefits
The anticipated salary range for fully qualified candidates is $245,000–$260,000 USD annually. Additionally, Arcus offers participation in stock programs, a performance‐based bonus, and a comprehensive benefits package. Further information about our total rewards program can be found here: https://arcusbio.com/careers
Equal Opportunity & Disability Statement
Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, non‐disqualifying physical or mental disability, national origin, veteran status, or any other legally protected status. EOE/AA/Vets.
Physical Requirements
Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, in groups, and over the telephone. This is primarily a sedentary office classification, although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.
#J-18808-Ljbffr