2.Design and carry out explorative, mechanistic research on oncogenic target validations, biomarker discovery, drug resistance and beyond
3.Analyze experimental data to evaluate new molecules’ potency in target engagement in cellular assays.
4.Maintain accurate records of experiments, analyze and interpret the results, present summaries, and generate reports of the studies.
5.Work in close collaboration with discovery team and communicate results in a timely manner.
6.Supervise research associates in designing, executing experimental plans.
1.PhD in molecular biology, cell biology, cancer biology, immuno-oncology or other biological disciplines.
2.PhD (Preferred) with 5-10 experience in drug development or immunoncology research experience.
3.Experience with molecular/cell biology techniques such as immunoblots, in-cell western, ELISA and bio-luminescence as well as other detection methods.
4.Experience in cellular assay development, optimization, validations.
5.A major plus for expertise in flow cytometry and high content imaging techniques.
6.Ability to manage multiple projects and proficiency as a scientific leader that designs, execute or lead associate to execute, and manages research plans,
7.Highly independent and organized with proficient verbal and written communication skills申请该职位
• Provide preclinical safety expertise and strategy for pre-clinical and clinical development programs from pre-clinical drug candidate selection to IND enabling and clinical trials
• Apply a broad understanding of toxicology, pharmacology, DMPK and regulatory sciences to design all types of toxicology studies required to support drug development of biopharmaceuticals
• Ensure that the preclinical safety plan is aligned with the clinical development plan and regulatory guidelines (ICH, FDA, GLP, etc.)
• Serve as Preclinical Safety team leader for multiple programs and contribute to the program’s goals and deliverables
• Identify and manage contract research laboratories (CRO) for preclinical safety studies; review reports; ensure they are using systems and processes in compliance with all relevant regulatory standards
• Write and review documents for INDs / regulatory section submissions; represent the company as the pre-clinical toxicology expert before regulatory authorities
• Serve as a subject matter expert to provide input for due diligence of potential external partnership programs
• 10+ years of combined toxicology, drug development and regulatory experience in a biotech, biopharmaceutical or CRO setting
• Extensive knowledge and expertise with in vitro and in vivo toxicology study conduct and reporting
• Familiar with applicable regulatory guidelines; prior experience with regulatory agency interactions is preferred
• Proven leadership and management skills, including the ability to interact effectively with CRO personnel and internal/external experts for the conduct of toxicology studies
• Good communication and technical writing skills in English. Capable of engaging in scientific dialog among large groups of scientists, senior management, and external scientific experts
• Ph.D. or equivalent in Toxicology or closely related field
• Toxicology board certification is a plus申请该职位