Scientist (PK/PD)

Major Responsibilities：

• Define PK,PK/PD, biopharmaceutical requirements in project (clinical) development  plans and appropriate strategies in accordance with the Chinese Health Authorities requirement.
• Understand clinical implication of the PK,PK/PD results.
• Interpret and represent PK, PK/PD data generated during the development and present in a clear and concise manner.
• Proactively manage links with other functions to ensure that pre-clinical and clinical PK/PD information are used optimally.
• Directly or indirectly take the lead on appropriate pharmacokinetic/biopharmaceutical studies.
• Prepare summary information for internal and external Advisory panels, Investigator meetings and Health Authorities as part of the regulatory approval process. This includes PK/PD components of CTA applications and NDA filings in China.
• Coordinate with appropriate sub-team members and other LF experts and / or prepare(when needed)summary documentation on drug metabolism and pharmacokinetics as required by ethics committees and Has(IB,BB,CTA/IND ,responses to HAs).
• Prepare, compile and review appropriate sections of CTA dossiers/ NDA documents.

Requirement：

• PhD/ Pharm.D.Level scientist with biological background, or a Masters degree with at least 3 years relevant experience.
• Fluent English (oral and written.)
• 2-3 years experience in drug development or a relevant environment (e.g. Clinical Pharmacokinetics).
• Proven knowledge of PK and PK/PD evaluation techniques, experience in working in project teams (preferably global)and knowledge of regulatory requirements.