Salary: strong>20-40K
Experience requirements: strong>Unlimited experience
Educational requirements: PhD or above
Job Description: strong>
Job description:
Job Responsibilities:
Lead the design, detection, and interpretation of biomarkers for the project, and provide clinical biomarker strategies for target development, medication strategy, indication selection, pharmacodynamic endpoints, patient selection, and accompanying diagnostic development based on preclinical and clinical data
(1) By combining targets and the biological basis of diseases, we can gain a deeper understanding of target characteristics, drug action mechanisms, and resistance mechanisms. By combining preclinical data and closely collaborating with preclinical teams, we can fully interpret preclinical data, scientifically improve preclinical experimental model design, and support clinical development strategies; Based on preclinical data and specific clinical research needs, design clinical trial biomarkers, fully analyze biomarker data and clinical data, and provide clinical biomarker strategies for target development, medication strategy, indication selection, pharmacological endpoints, patient selection, and concomitant diagnosis development
(2) Lead the writing of the biomarker section of the clinical trial protocol, develop the data analysis plan, and participate in the clinical protocol ICF、 Review and development of manuals for central laboratories, as well as drafting and reviewing research reports
(3) Ensure that biomarkers are implemented in accordance with the requirements of the clinical trial protocol and project schedule, including supplier selection and management, correct and appropriate sample collection strategies, support for HGRAC applications, methodology establishment or transfer, clinical sample testing, and troubleshooting during the trial process
(4) Provide biomarker data analysis and interpretation to ensure compliance with FDA, NMPA, and EMA regulatory requirements, provide scientific and reasonable interpretation plans, support the development of data analysis plans, real-time data quality and result analysis, and provide biomarker level strategies and opinions for clinical development
(5) Support biomarker accompanying diagnostic development
(6) Pay attention to and summarize emerging biomarker detection technologies, and evaluate new technologies used in clinical trials
(7) Timely and effective communication between internal departments and external organizations
(8) Provide scientific and technological consultation related to biomarkers
2. Clinical trial biomarker detection, analysis, and management:
(1) Participate in the writing of clinical protocol biomarkers, drafting of data analysis plans, drafting and reviewing research reports
(2) To provide scientific and technological support for screening suitable testing suppliers CRO companies, establish technical standards for service contracts, and manage scientific and technological aspects of testing suppliers
(3) Technical support for documents such as the central laboratory manual and genetic office application
(4) Participate in various clinical research conferences and assist in the design and production of related PPTs
(5) According to GCP requirements, experimental plans, and company SOP regulations, suppliers are required to conduct scientific and technical management, report project quality status in a timely manner, present problems, analyze problems, and propose solutions
(6) Provide training and consultation on clinical trial related issues
3. Department management:
(1) According to the clinical project requirements, assist the director in arranging subordinates to join the project team, drive cross departmental work, organize timely and effective communication between internal departments and external organizations involved in the work, summarize and share project promotion experience
(2) Assist the director in building corresponding translational medical technology and management platforms according to job requirements, establish and maintain external resources
(3) Assist the director in recruitment, personnel assessment, departmental administrative affairs, team building, and demonstrate the spirit of a scientific team by guiding, training, or motivating team members
(4) According to project requirements, establish an inspection/monitoring/auditing team to conduct inspections/monitoring/auditing of outsourced units, and organize the establishment and updating of CRO databases
4. Complete other tasks arranged by the company
Job requirements:
Qualifications for the position:
Educational requirements:
PhD or above
Professional requirements:
Immunology, biology, medicine, pharmacy and other related majors
Experience requirements:
Familiar with the development process of innovative drugs, with 4-6 years of experience in translational medicine, and experience in preclinical and clinical translational medicine projects is preferred
More than 3 years of experience in clinical biomarker or accompanying diagnostic development
Familiar with the principles, processes, and relevant guidelines and regulations of clinical sample testing, including but not limited to flow cytometry, ELISA, IHC, NGS, etc., with independent experience in the development, validation, and testing of biomarker methods
Good scientific thinking and communication skills, as well as excellent English communication abilities
Requirements for the next job level: Meet the company's promotion management regulations for the length of service or relevant work experience requirements
Skills and ability requirements:
Master immune detection methods (IHC, ELISA, MSD), molecular detection methods (mainly FISH, ISH, NGS), flow cytometry, and international cutting-edge biomarker detection technologies such as CRISPR-Cas9/sc RNA seq CYTOF、 Technologies such as spatial omics
Quality requirements:
Have good scientific thinking and logical abilities, as well as communication and expression skills
Strong literature review and summarization skills, as well as excellent English listening, speaking, reading, and writing abilities
Professional knowledge, skills, professional qualifications, language proficiency, professional competence, mandatory training and assessments, etc
Good teamwork awareness and execution ability, understanding and recognition of company culture and philosophy, dedication to work, honesty and integrity
Please send your CV or resume as an attachment to the following email address:
mailto: rbhr@hrcenter.co.uk
With the subject line formatted as: 'Name + Position + Company Name + Location'.