Clinical Pharmacology Head

Responsible for the establishment and management of the company's clinical pharmacology team. Responsible for drafting and reviewing the clinical pharmacology sections of the company's early clinical program; follow-up and tracking the progress of clinical pharmacology studies. Prepare relevant documents for clinical protocols, IBs, study reports et al, and provide supports for IND and NDA applications. Responsible for designing and performing analysis such as NCA analysis, Pop-PK analysis, and PK-PD analysis and interpreting clinical pharmacokinetic & pharmacodynamic data. Responsible for close interactions with vendors on pharmacological studies. Participate clinical development strategies/plans for novel drug candidates in oncology and non- oncology indications as part of a cross-functional project team. Provide communication of PK data in ongoing and completed studies with cross functional teams and relevant agencies. Participate in regulatory authority interactions and network with key opinion leaders. Work and partner with internal and external (CRO, investigator) stakeholders Adhere to and implement quality standards and SOPs in clinical pharmacology development. Maintain current knowledge of government’s guidance on pharmacology requirement for novel drug clinical trial design and NDA application. Minimum master’s degree in clinical pharmacology, Quantitative Pharmacology with deep understanding of the principles of Pharmacokinetics and Pharmacodynamics (PK&PD). Doctorate level degree is preferred. 10+ years of experience in modeling and simulation in the field of clinical pharmacology in pharmaceutical companies or CRO companies. Proficient in the use of quantitative pharmacology related software (such as NONMEM, Monolix, Phoenix NLME, R, SAS, SimCYP, GastroPlus, etc.) is preferred. Experience in data management and biostatistics. Strong knowledge of clinical trial process and regulatory requirements (US, EU, and China). Excellent interpersonal skills and a demonstrated ability to work well within team structure is essential. Strong written and verbal communication skills. #J-18808-Ljbffr Jacobio Pharma