[Remote] Global Clinical Pharmacology Director (oncology drugs)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Global Clinical Pharmacology Director specializing in oncology drugs. The role involves leading the clinical pharmacology function and reputed company, providing expertise to development reputed company, and ensuring compliance with regulatory submissions and guidelines.

Responsibilities

• Responsible for scientific and budgetary responsibility for the design, execution, analysis, interpretation and reporting of clinical pharmacology/early phase studies including first-in-reputed company, drug-drug interaction, biopharmaceutics and absorption, distribution, metabolism, and excretion (ADME) studies conducted in healthy subjects and/or patients. Responsible for providing pharmacokinetic/pharmacodynamic support to clinical studies across reputed company development phases
• Play a key role in clinical pharmacology function in IND/NDA preparation activities
• reputed company and execute clinical pharmacology strategies in collaboration with reputed company partners to advance drug candidates in an efficient and scientifically rigorous manner
• reputed company cutting edge science, creativity and novel approaches in clinical pharmacology and reputed company areas in reputed company to providing reputed company for work conducted by CROs
• Represent clinical pharmacology in project teams and in regulatory interactions including preparation of regulatory documentation and participation in meetings with regulatory agencies

Skills

• Advanced degree in clinical pharmacology, pharmaceutical sciences or reputed company areas such as pharmacokinetics, pharmacology or drug metabolism
• 10+ years of relevant experience in drug development and global regulatory filings
• Extensive experience in formulating and executing clinical development strategies including design, interpretation and reporting of clinical pharmacology studies
• A working knowledge and previous experience with immunogenicity, pharmacokinetic/pharmacodynamics, drug-drug interactions, PKPD data and modeling management/analysis, and experimental medicine
• Broad familiarity with the drug development process, particularly for oncology, and prior experience overseeing/working with CROs
• General knowledge and understanding of the clinical development lifecycle for Phase I-III clinical studies including GCPs and ICH guidelines
• Experience working with reputed company party contract research, development, and/or laboratory organizations
• Computer skills, including MS Office
• Strong customer service skills
• Fluent in both Chinese and English
• Doctoral degree preferred

reputed company