Save Job Back to Search Job Description Summary Similar Jobs Worls's leading science and technology and unique strategy, focus on neuroteophi Senior managment team of rich experiences and complementary expertis. About Our Client My client was founded with its mission to focus on novel medicines for neurodegenerative diseases and neurological injuries. Job Description Responsible for designing and implementing a Clinical Pharmacology plan that conforms to appropriate regulatory guidelines such that rational development and registration of drug candidates can be rapidly achieved in China. Serves as the Clinical Pharmacology representative on drug development and clinical sub-teams and provides clinical pharmacology expertise and leadership to projects. Plans and directs clinical pharmacology components of clinical programs (including clinical development plan) and studies (including design, clinical phase oversight, synopsis preparation and reporting). Leads multifunctional study team to design, deliver and report the assigned clinical pharmacology studies and has overall scientific accountability for the designated studies. Responsible (with Clinicians and Statisticians) for ensuring appropriate dose-finding strategies during clinical drug development that will ensure optimal doses and dosage regimens in patients Accountable for the development and implementation of a clinical modeling and simulation plan based on agreed upon better practices (i.e. model-based drug development) in collaboration with Pharmacometrics. Responsible for use of quantitative methods to integrate knowledge of pharmacokinetics (PK), pharmacodynamics (PD), patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development. Responsible for appropriate summarization and interpretation of results of PK-PD analyses with respect to their impact on development and clinical use of drugs. In collaboration with global Business Unit, evaluates PK (and/or PD) and safety results among ethnic groups to contribute to the faster submission and authorization in China utilizing global study results. Provides clinical pharmacology support and leadership in the preparation and defense of regulatory submissions. Organizational Relationships: Solid line report to CMO. The Successful Applicant Educational: Pharm. D., Ph.D., or equivalent training or experience in pharmacokinetics, pharmacometrics, clinical pharmacology or related discipline. Considerable organizational awareness (inter-relationship of departments, business priorities, etc.) 5-year experience in pharmaceutical industry in relevant roles. Clinical pharmacology: demonstrates cursory understanding of the following: 1) principles of PK, PK-PD and pharmacology relevant to drug candidates; 2) other relevant scientific disciplines, including drug metabolism, drug transport, formulation sciences, biopharmaceutics, pathophysiology and therapeutics; 3) quantitative modeling and simulation principles Communication skills: Demonstrates ability to effectively present PK/PD data, clinical pharmacology development plans and strategies to various audiences in both verbal and written form (English and Mandarin); demonstrate ability to write PK/PD results, interpretations (including impact) and conclusions for clinical study reports and regulatory documents that are clear and concise. Regulatory knowledge: Understands and is able to apply appropriate China FDA, US FDA, EMA and ICH guidelines in the design of clinical development plans and studies with close supervision What's on Offer A robust and balanced pipeline with first-in-cliass potential assets, backed by enabling technologies Broad stategic partership with domestic and international enterprises Contact Ada Yang Quote job ref 4203124 Phone number +86 10 5969 0539 Job summary Function Life Sciences Specialisation Biotechnology What is your area of specialisation? Healthcare / Pharmaceutical Location Beijing Contract type Permanent Consultant name Ada Yang Consultant phone +86 10 5969 0539 Job Reference 4203124
