Director/Sr. Director Clinical Pharmacology (PK/PD)

Summary:

At Arcus, the Director, Clinical Pharmacology functions as the Clinical Pharmacology (CP) team representative for small molecule and biotherapeutic projects at various stages of clinical development (Phase 1-3) and is responsible for all aspects of clinical pharmacology-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, and communication of data in regulatory documents and meetings. This position will initially report into the Vice President of Clinical Development, and then into the Vice President of Clinical Pharmacology once hired.     

Essential Functions :

• Perform hands-on pivotal 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.

Collaborate with CROs to ensure delivery of regulatory-standard M&S analyses.

• Provide CP expertise into clinical development plans, including:
• Development of CP plan for clinical candidates
• Design, conduct, and interpretation of CP studies
• Analysis of data using advanced PKPD modeling and simulation methodologies
• Development and execution of the regulatory strategy (e.g IB, end of phase 1/2, and NDA/BLA)
• Develop CP strategy for projects at all stages of clinical development - IND to NDA/BLA - and to defend these strategies at internal and regulatory meetings.
• Function as the sole point of contact for all CP activities on projects at all stages of discovery and development and be able to influence team strategy using CP expertise.
• Collaborate with Biostatistics, Clinical Research, Clinical Operation, and Drug Metabolism 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.

Education & Experience:

• An advanced degree in Pharmaceutics/Pharmacy/Engineering/Statistics with demonstrated expertise in PKPD and strong quantitative skills.
• 8+ years of relevant industry experience required either in clinical pharmacology or M&S roles.
• Proven track record of expertise in leveraging advanced population modeling and simulations and clinical trial simulation techniques to inform clinical development decisions. Expertise with advanced 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.
• 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 required
• Strong publication and conference presentation track-record required.
• Ability to function effectively in a highly matrixed environment, and to actively and effectively participate in cross-functional project teams is required.
• Knowledge of late stage regulatory experience - especially NDA/BLA filing desirable

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.