IND-enabling Program Management
- Manage, direct and lead preclinical projects in a team environment; Work with clients to proactively identify the right strategy based on their unique program and help clients to select right studies, smartly coordinate the studies to move forward efficiently
- Monitor closely the progress of the project, coordinate with sponsors and internal expertise to design appropriate studies to meet regulatory requirements, ultimately to meet the project needs. Stay on the top of project with continues scientific and technical support. Proactively identify potential issuers and input the constructive suggestions
- Interact with clients, other key functions/business units within WuXi AppTec to facilitate the project development; Communicate directly (visiting host, holding TC and auditing, etc.) with national and international sponsors
- Service as an expert for all TOX-related discipline within TAD; Prepare documents package for IND filing; Search and prepare scientific references for project needs.
- Initiate issue-oriented agendas to facilitate effective team meeting discussion and able to summarize and provide guidance on follow-up strategies to ensure timely resolution of outstanding items.
- PhD or equivalence in biomedical/ pharmaceutical science with at least 5 years experience in pharmaceutical/biotech industry in preclinical development with strong toxicology expertise.
- Demonstrated successful leadership, planning and organizational skills with strong knowledge in pharmaceutical R&D from discovery to clinical development and regulatory registration;
- Familiar with relevant FDA, ICH, EMA/OECD and CFDA guidelines/regulation with hands-on experience on planning and execution of IND/CTA programs
- Team oriented work ethic and ability to work in cross-functional teams
- Excellent written and oral communication skills
- Regulatory writing experience and PMP certification will be a plus.
Primary Location: China – Shanghai
To apply please send your application to HR_Biologics@wuxiapptec.com.