Manager to Director, Clinical Pharmacology
Locations: Hayward, California | Brisbane, California | Remote, United States
At Arcus, the Manager to 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, Head of Clinical Pharmacology and Pharmacometrics.
- Provide CP expertise into clinical development plans, including:
- Developing the 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.
- Perform or guide pivotal analysis and interpretation of clinical PK/PD data, integrating clinical trial simulation strategies and disseminating the relevant risk/benefit implications to project development teams.
- 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 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 clinical pharmacology and strong quantitative skills.
- 3+ years of relevant industry experience required with strong small molecule development experience.
- Proven track record of expertise in leveraging advanced population modeling and simulations and clinical trial simulation techniques to inform clinical development decisions. Familiarity 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.
- 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 highly desirable
- Knowledge of biologics discovery and development is desirable.
- Position may require occasional evening and/or weekend commitment
- Position may require occasional travel (~15%), domestic and international.