RESPONSIBILITIES
1. Be responsible for overall pipeline build-up strategy for small molecule drug discovery from target selection, compound screening and optimization, candidate nomination to IND filing; and formulating discovery and preclinical development plan for small molecule innovative drugs in accordance with the overall development strategy and R&D strategy;
2. Be responsible for the formulation of specific implementation plans for small molecule innovative drug R&D projects; and to supervise, manage and guide the progress and quality of projects, and ensure that R&D related work is completed according to timeline;
3. Be responsible for the discovery and/or collaborative discovery work with external collaborators for small molecule innovative drug research and preclinical development, including candidate compound screening and evaluation, process development and technology transfer, and domestic and foreign registration;
4. Be responsible for research and evaluation of technologies and products related to small molecule innovative drugs, providing decision-making for the company's innovative drug pipeline, and providing technical support and evaluation opinions for the company's license-in opportunities of external cooperation projects;
5. Be responsible for establishing, leading and managing a small molecule drug discovery team, and constantly upgrading the research and development capabilities of the team in the area of small molecule innovative drugs.
QUALIFICATIONS
1. Major in pharmaceutical chemistry or chemistry, a Ph.D. degree; at least 10 years in a multinational pharmaceutical company or a well-known R&D institution engaged in the research and development of innovative drugs;
2. Familiar with the whole process of development of innovative drugs, with rich experience in the development and evaluation of new molecular drug innovations, and successful cases of innovative project development;
3. Strong leadership skill and experience in people management, and high standard business integrity and self-motivation.
Previous: BD Manager
PRIMARY DUTIES:
• Support regulatory affairs management and operational processes.
• Liaison with CRO and other service providers for drug registration conduct.
• Support and track documentation and archiving for IND and NDA filing.
RESPONSIBILITIES:
• Adhere to corporate SOPs and local WIs in the assisting Project Lead with drug application planning, documentation, reporting, archiving, dossier filing, CDE review tracking, and CDE communication meeting.
• Assist in the preparation, review, modification and finalization of drug application dossiers with line functions or CRO.
• Assist in the preparation and submission of drug application package to CDE.
• Assist to track CDE review process, reply CDE question and submit supplementary documents.
• Assist in the dossier preparation, meeting request and holding, feedback tracking for CDE communication meeting.
• Assist in the regulatory documents preparation and filing requirements for clinical trial.
• Track the updates of NMPA and CDE regulatory policies, regulations and guidelines.
QUALIFICATIONS:
• At least bachelor’s degree in health science, e.g., pharmacy, pharmaceutics, medical chemistry, pharmacology, or related major; Master’s degree is preferred.
• 2-3 years industry experience in drug regulatory affairs and conduct.
• Basic understanding of ICH CTD and other guidelines, NMPA and CDE regulatory requirements.
• Familiarity with working procedures, regulations and guidelines issuance of NMPA and CDE.
• Proficiency in English (written and oral) and familiarity with standard IT office tools.
• Excellent planning, organization and problem-solving skills.
•Good communication and interpersonal skills.
Previous: CRA/ CTA
PRIMARY DUTIES:
• Support clinical trial management and operational processes
• Liaison with CRO and other service providers for clinical trial conduct
• Support and track documentation and archiving for IND and NDA filing
RESPONSIBILITIES:
• Adhere to corporate SOPs and local WIs in the assisting Clincial Project Lead with trial planning, documentation, conduct, reporting, archiving, and clinical center/vendor invoicing.
• Assist clinical project team with meeting logistics and planning, such as advisory board meeting, investigators meeting, etc.
• Review and approve site / CRO invoices against contract for accuracy and budget track
• Prepare clincial trial meeting minutes and follow through cross-functional team actions
• Support drug supply management and drug depot for shipping, labeling, packaging and hospital storage tracking.
• Review and track all vendors and clinical center invoices against contract scope of work, and ensure invoices are accurately reconciled and paid.
• TMF are archived at the time of trial completion/closure.
QUALIFICATIONS:
• At least bachelor’s degree in health sciences, e.g., pharmacy, nursing, biochemistry, medicine or related major; Master degree is preferred.
• 2-3 years industry experience in clincial trial management and conduct.
• Basic understanding of ICH guidelines, GCP and regulatory requirements.
• Proficiency in English (written and oral) and familiarity with standard IT office tools.
• Excellent planning, organization and problem-solving skills.
• Good communication and interpersonal skills.
Previous: Regulatory Affairs Specialist
Previous: CRA/ CTA
Previous: Clinical Project Manager