临床研究负责人-北京

该职位来源于猎聘 岗位职责描述 / Job description

• Plans, designs, and oversees clinical development plans as required throughout all stages of drug development with operational assistance from a Clinical Project Manager and guidance from Senior Clinical Science Lead.
• With the clinical team, tracks the emerging clinical profile of the drug, and keeps line management informed of changes in the profile as they occur. Must be fully knowledgeable about the clinical profile of programs on which studies are being conducted.
• Serves as the Medical Monitor (MM) for clinical trials, to address patient eligibility and protocol questions in cooperation with the contract research organization (CRO) MM
• Reviews safety data for routine medical data review, trend review, and safety signals from ongoing trials, along with the Medical Safety Department personnel.
• Provides professional input and support during statistical evaluation, data coding, and data cleaning
• Leads other team members in the data review, analysis, and reporting of assigned clinical studies, with responsibility for overall content and accuracy of study report and final sign-off
• Oversees internal and external dissemination of results to the Development Team, Investigators, etc.
• Collaborate with Clinical Operations and other functional groups to ensure timely and appropriate completion of study reporting
• Helps ensure cross-functional integration, coordination, and alignment to enable effective and efficient CDP implementation
• Leads clinical contributions to all regulatory documents, including Investigator Brochures, regulatory advice meetings, NDA/BLA/MAA. Leads the resolution of clinical queries from drug regulatory agencies, takes a lead role in reviewing responses to regulatory queries
• Stays abreast of literature, regulatory guidelines, internal guidance on clinical trial conduct, including Good Clinical Practice and internal SOPs, regulations for specific projects to which assigned, in order to be a team resource of clinical pharmacology knowledge in terms of both medical background and clinical trial design
• May support the clinical lead in assessing potential in-licensing opportunities, as requested by line management
• Ability to produce and present quality scientific papers at external meetings and for publication
• Manage and initiate external collaborations with world-leading clinical experts to forward clinical science in the assigned therapeutic area 专业技能 / Technical Knowledge & Skills
• Must possess broad knowledge of the pharmaceutical industry and of pharmaceutical practice, knowledge and understanding of clinical research functions and of involved areas /stakeholders like e.g. pharmacovigilance, regulatory affairs, clinical operations, medical affairs, marketing functions, investigational product supply, and good knowledge of relevant international and country/region specific laws and regulations (e.g. ICH, NMPA guidance).
• Must possess a high level of professionalism and personal integrity. Excellent oral and written communication skills in English, good organizational and communicational skills, and the ability to manage multiple tasks is required. Should have the ability to read and interpret documents. Ability to write routine reports and correspondence. 核心能力 / Core Capability
• Ability to work with executives and communicate abstract concepts.
• Ability to present to a high level of the organization and groups outside of the organization.
• Ability to perform computations/AI such as percentages, ratios, and other simple viables.
• Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis.
• Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems. 岗位要求 / Requirements
• Minimum of an MBBS/MD/PHD (or equivalent) in clinical medicine or life sciences.
• over than 7-10 years of experience in the pharmaceutical industry, clinical practice, or clinical research. a combination of experience and/or education will be taken into consideration. at least having 5 years pre-launching clinical development experience, having early-stage development experience will be rather preferred
• Ability to read and interpret comprehensive and intricate research documents.
• Ability to write scientific reports and technical correspondence in English.
• Ability to work with executives and communicate abstract concepts.
• Ability to present to a high level of the organization and groups outside of the organization.