北京招聘

Job Responsibility:

？  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 best 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 reportto CMO.

？  Collaborates closely with project team members, particularly with other triad colleagues from Clinical Development, Statistics and Pharmacometricians.

？  Provides matrix leadership to a wider Clinical Pharmacology team (e.g. Pharmacometrics, Clinical Assay/Biomarker Group), particularly for larger projects.

？  Other important partnerships can include Development Operations, Pre-clinical DMPK, Drug Safety, Statistician/Data management, etc.

任职资格:

Qualifications and Attributes:

？  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.

Technical Competencies

？  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; and 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

4B Technologies (4B Tech) is a start-up biopharmaceutical company with the goal of developing innovative treatment of diseases of nervous system through internal proprietary technologies and expertise as well as partnerships. 4B Tech management team comprises veteran business and scientific leaders who have passion, industry experience and track record in neuroscience drug discovery/development as well as business and finance operations.
4B Tech began its full operation in 2018 with the main R&D facilities located in Suzhou (preclinical discovery) and Shanghai (clinical development), China.

福贝生物科技（苏州）有限公司是一家致力于开发针对神经系统疾病的创新药物，和开拓相关前沿技术平台的生物制药高新技术企业。坐落于苏州生物纳米园区，占地2500平方米。
福贝生物由国际顶尖级科学家领衔，已建立了由来自于企业运营、新药研发、学术突破和金融投资领域精英人士组成的领导团队。福贝生物追求创新、活力、成长、以患者为本的企业文化，具有宏远的企业发展规划，公司员工将与公司共同进步和发展。