Expert/Director of Preclinical Research (Pharmacology, pharmacokinetics, Toxicology) ???????/???????????? at Qilu Pharmaceutical in Boston, Massachusetts

Job Description:

• 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 competition in the field of disease and positioning strategy of the project from the target disease field of the project; To comprehensively formulate the overall and current objectives of pharmacological research, form the research framework and program points, and coordinate the resources and strength inside and outside the professional team with the organization to achieve the objectives and functions of professional research;
• Formulation and guidance of pharmacology, pharmacokinetics and toxicology research strategies from project initiation to product launch; supervision and guarantee of reliability, scientificity, rationality, efficiency and cost-benefit ratio of research results through the construction and improvement of internal procedure-regulation-technical requirements and the guidance and review of pharmacological research of specific projects;
• Plan and guide the technical capacity building of pharmacological research system and train senior professionals in tumor/non-tumor pharmacology, pharmacokinetics and toxicology research;
• 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 the pharmacology, pharmacokinetics and toxicology research requirements of various products throughout the life cycle, formulate research strategies that meet regulatory needs, and coordinate with the pharmaceutical administration to carry out international and domestic regulatory communication on pharmacology;
• According to the company's project planning and needs, review the evaluation and strategy formulation of pharmacology, pharmacokinetics and toxicology research related content in the whole life cycle of external cooperation projects, and provide strategies and programs for project initiation, introduction and development;
• Other key work related to the development and planning of research systems in tumor/non-tumor pharmacology, pharmacokinetics and toxicology, especially pharmacokinetics, quantitative transformation, MIDD system development and planning, as well as non-clinical work related to the whole life cycle of the project

• PhD degree, major in pharmacology/medicine/biology, pharmacokinetics and toxicology related to tumor or non-tumor (autophagy, neuro-metabolism, cardiovascular, etc.), with more than 8 consecutive years of working experience in a pharmaceutical company or drug development biotech;
• At least 8 years of industry working experience in project-based innovative drug oncology, non-tumor pharmacology/biology (autoimmune/ neurological/ metabolic/ cardiovascular), pharmacokinetics, toxicology research directions, and 10 years of continuous or more experience in corresponding team management, technical capacity building and project development;
• Senior research strategy-plan-protocol and successful implementation experience in oncology, non-tumor pharmacology (autolitism/neurologic/metabolic/cardiovascular), pharmacokinetics and toxicology at all stages of the whole life cycle (project initiation, discovery, IND, clinical and post-marketing) of innovative small molecule and biotechnology drugs;
• Have a deep understanding of various types of tumor, non-tumor disease biology (autoimmune/neurological/metabolic/cardiovascular) and non-clinical in vivo and in vitro models, as well as translational research, pharmacokinetics, toxicology research, and can establish and continuously improve the systematic capabilities of various types of research, including technical capacity building, research norms and templates, processes and systems;
• Have a deep understanding of relevant regulatory guidelines and review practice requirements, capable of communicating with various planning and regulatory agencies, and able to integrate regulatory requirements and relevant professional drug administration registration requirements into the team's research practice;
• Have the ability and experience to use internal and external resources and cooperate with external teams such as toxicology, pharmaceutical substitution, transformation and clinical to build complex system capabilities and processes, and implement clinical value and clinical demand-oriented R&D concepts into the team's specific work system and practice;
• Ability 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.
• Senior experience in tumor/autoimmune/neurological/metabolic/cardiovascular direction is preferred, participate in the development of industry rules and norms in the technical field, and have domestic and international industry influence is preferred; Experience in the field of small molecules, antibodies, nucleic acid drugs and gene therapy is preferred;
• The specific job rank will be determined according to the comprehensive qualifications of the candidate.