Responsible for in vivo animal efficacy, pharmacokinetic, and toxicology studies of innovative biologics, including: CRO screening, negotiation, and relationship maintenance; designing overall nonclinical study plans and specialized experimental protocols; overseeing CRO execution throughout the process, analyzing results, and reviewing reports; evaluating project progress and managing potential risks.
Responsible for compiling, writing, and coordinating nonclinical sections for IND submission documentation and other regulatory support activities.
Participate in drafting regulatory dossiers, project applications, patents, manuscripts, and other documents; capable of independently completing a full set of regulatory submission documents or technical proposals in at least one specialized area under supervision.
Conduct due diligence, literature research, and evaluation of innovative biologics projects.
Ph.D. degree, or Master's degree with at least 3 years of relevant work experience.
Proficient in literature reading and scientific literature retrieval.
Experience in metabolic diseases or oncology is preferred; experience in ADC (antibody-drug conjugate) R&D is highly desirable.
Excellent communication skills, strong sense of responsibility, and a team-oriented mindset.