Sr. Director, Clinical Pharmacology And Pharmacometrics

Summary:

At Arcus, the Snr Dir, Clinical Pharmacology and Pharmacometrics (CPP) functions as the team representative for small molecule and biotherapeutic projects at various stages of clinical development (Phase 1-3) and is responsible for all aspects of CPP-related support for small molecule and biotherapeutic products, including design and execution of clinical pharmacology studies, design of clinical pharmacology portion of other clinical studies, analysis and reporting of data including advanced modeling and simulation (M&S), and communication of data in internal and external meetings. This position will report into the Vice President of CPP.

Essential Functions:

• Function as the sole point of contact for all CPP activities on projects at all stages of discovery and development and be able to influence team strategy using CPP expertise.

• Provide CPP expertise into clinical development plans, including:

• Develop CPP strategy and plan for projects at all stages of clinical development - IND to NDA/BLA - and to communicate these strategies at internal, external, and regulatory meetings.

• Design, conduct (through CROs), interpretation, and reporting of CPP studies.

• Ensure modeling and simulation (M&S) analysis and interpretation of clinical PK/PD data; integrate clinical trial simulation strategies and disseminate the relevant risk/benefit implications to project development teams. Guide internal modelers and CROs to ensure delivery of regulatory-standard M&S analyses.

• Develop and execute the CPP regulatory strategy (e.g. IB, end of phase 1/2 meetings, and NDA/BLA)

• Collaborate with Biostatistics, Clinical Research, Clinical Operations, and Research colleagues for the appropriate design of Phase I-III studies; 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/M&S activities - e.g. draft department SOPs, establish quality systems, create plan/report templates, etc.

• Manage junior (up to Dir level) scientists - recruit, train, and mentor junior scientists to peak performance

Education & Experience:

• An advanced degree in Pharmaceutics/Pharmacy/Engineering/Statistics with experience in regulatory filings including BLA/NDA is required

• Ability to communicate complex pharmacological concepts clearly and effectively to a wide range of staff members and colleagues, including those with technical and non-technical backgrounds, is critical

• Ability to function effectively in a highly matrixed environment, and to actively and effectively participate in cross-functional project teams is required.

• Ability to create a risk-based CPP strategy for small/large molecules and deliver appropriate package for various stages of development including design and execution of clin pharm studies - hAME, organ impairment, DDI, etc.

• Expertise in leveraging advanced population M&S techniques to inform clinical development decisions required. Some expertise in modelling software (e.g. WinNonLin, NONMEM, GastroPlus/SimCYP, MATLAB, Berkeley-Madonna, etc) is desirable.

• Strong publication and conference presentation track-record required.

• 10+ years of relevant industry experience required in clinical pharmacology roles

Other Information

• Position may require occasional evening and/or weekend commitment

• Position may require working with biological and/or chemical hazards

• Position may require occasional travel (~15%), domestic and international.

Title will be commensurate with the number of years of relevant experience.

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 $250,000 - $280,000 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.

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 identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets