Director, Clinical Pharmacology
Abata TherapeuticsSalary not specified
Full Time
Expert & Leadership (9+ years)
Director, Clinical Pharmacology (Temporary) at Vir Biotechnology
San Francisco, California, United States
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
BiopharmaceuticalIndustries
Requirements
Candidates must possess a PhD or PharmD with relevant training in clinical pharmacology, pharmacokinetics, pharmaceutics, or a related field, and have at least 10 years of industry experience in Clinical Pharmacology. Extensive experience with biologics, including monoclonal antibodies and bispecifics, is required. Experience leading clinical pharmacology strategy for oncology and/or immunology indications, along with familiarity with immune modulating agents, is preferred. Proficiency in standard PK analysis and graphing programs such as Phoenix WNL, Graphpad, and R is necessary. The role requires a deep understanding of multidisciplinary drug development requirements and the ability to work effectively across functions. Candidates must also have extensive experience leading translational and clinical pharmacology work from first-in-human dose selection through market authorization, and experience contributing to clinical pharmacology plans and regulatory submissions.
Responsibilities
The Director, Clinical Pharmacology will lead the design, execution, interpretation, and reporting of clinical pharmacology data throughout drug development. This individual will represent clinical pharmacology on cross-functional project teams and subteams, developing fit-for-purpose clinical pharmacology strategies to support development and regulatory decisions. Responsibilities include collaborating with internal and external cross-functional teams, such as clinical research, operations, biomarkers, bioanalytical, biometrics, CMC, and regulatory, to advance programs. The role involves leading the design and execution of Phase 1 clinical pharmacology studies, providing expertise in dose selection and optimization, and leveraging modeling and simulation approaches. Additionally, the Director will author and provide technical input for regulatory documents and submissions, and may guide junior clinical pharmacologists in data analysis and reporting.
Skills
Clinical Pharmacology
Drug Development
Clinical Trial Design
Data Analysis
Regulatory Strategy
Cross-functional Collaboration
Quantitative Modeling
Vir Biotechnology
Develops monoclonal antibodies for infectious diseases
About Vir Biotechnology
Vir Biotechnology develops treatments that leverage the immune system to combat infectious diseases. The company uses a proprietary monoclonal antibody platform combined with machine learning to create a database of human antibodies, which aids in developing effective medicines. Their pipeline includes candidates for hepatitis B, hepatitis delta, HIV, and various viruses like influenza and COVID-19. Vir stands out by collaborating with industry leaders and organizations to accelerate scientific advancements, with the goal of transforming lives through innovative therapies.
San Francisco, CaliforniaHeadquarters
2016Year Founded
$640.6MTotal Funding
IPOCompany Stage
AI & Machine Learning, Biotechnology, HealthcareIndustries
501-1,000Employees