What are the responsibilities and job description for the Expert in toxicology position at Qilu Pharmaceuticals?
Job Responsibilities
- Deeply understand the development goals and clinical value orientation of the project, as well as competition/clinical research/supervision/intellectual property/transformation and other cross-professional collaborative research needs, and deeply analyze the safety competition and positioning strategy of the project from the target disease field of the project. To comprehensively formulate the overall and current objectives of toxicology research, form the research framework and program points, and coordinate with the organization of resources and strength inside and outside the professional team to achieve the objectives and functions of professional research;
- Formulate and guide toxicology strategies from project initiation to product launch, supervise and guarantee the reliability, scientificity, rationality, efficiency and cost-benefit ratio of research results through the construction and improvement of internal procedure-standard-technical requirements and the guidance and review of toxicology research of specific projects;
- Plan and guide the technical capacity building of toxicology research system and train toxicology professionals;
- Timely analyze and solve cross-team research problems within the scope of the overall goal of the major or related to the major, guide or collaborate with resources to solve difficult problems within the major, conduct comprehensive discussions on stage results and form professional judgments, and put forward discussions and suggestions or reference for decision-making;
- Have a deep understanding of the technical principles and applications of the major, and creatively apply professional technologies to project-related special matters or cross-professional research support;
- Deeply understand the guidelines and practices of various European, American and Chinese regulatory agencies for toxicology and safety research requirements of various products throughout the life cycle, formulate research strategies that meet regulatory needs, and coordinate with the drug administration to carry out international and domestic regulatory communication on toxicology; 7. According to the company's project planning and needs, review the evaluation and formulation of toxicology related content in the whole life cycle of external cooperation projects, and provide strategies and schemes for project initiation, introduction and development;
- Other key work related to toxicology system development and planning and project lifecycle toxicology;
- Doctor, major in pharmacology/pharmacy/Medicine/biology, with more than 15 years of continuous working experience in pharmaceutical companies or drug development biotech.
- More than 15 years of industry experience in innovative project-based drug toxicology research and 10 years of continuous experience in corresponding team management, technical capacity building and project development;
- Experienced in the successful implementation of toxicological research strategies, plans and protocols at all stages of the entire life cycle (project initiation, discovery, IND, clinical and post-market) of innovative small molecule and biotechnology drugs;
- Have a deep understanding of toxicology in all stages of product research and development in various disease fields, and be able to establish and continuously improve the systematic capabilities of various research, including technical capacity building, research norms and templates, processes and systems;
- Have a deep understanding of drug administration regulations and guidelines related to toxicology and safety research of small molecule and biotechnology drugs in Europe, the United States and China, and the requirements of review practice; be competent in communicating with various planning and regulatory agencies; be able to integrate the requirements of toxicology and related professional drug administration registration into the research practice of toxicology team in a complete and in-depth way;
- Have the ability to use internal and external resources to lead the team to develop new technologies, new tools and new methods, solve problems that cannot be solved by existing methods, create considerable project value and significantly reduce development risks.
- Participate in the formulation of industry rules and norms in the technical field, with domestic and international industry influence is preferred;
- Experience in ADC, nucleic acid drugs and gene therapy is preferred;
- Experience in FDA review is preferred
- The specific job rank will be determined according to the comprehensive qualifications of the candidate.
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