该职位来源于猎聘 Responsibilities
- Develop clinical operational strategy and ensure clinical research programs are executed with quality and efficiency, on-time, within budget, and to meet company objectives.
- Translate asset strategy into operational execution by developing the clinical operations plan (or strategy) and connecting the science with the business, operations, and patients.
- Identify and evaluate risks and mitigations at program level to achieving the asset strategy.
- Interacts with and influences all levels of management and cross-functional team members to achieve program objectives and represents Clinical Operations at senior leader cross functional meetings.
- Reviews and provides clinical operations content to clinical and regulatory documents.
- Manage overall budget management across multiple studies.
- Responsible for bringing the best out of our talent, mentoring and supporting development to enable growth including direct management of study manager(s).
- Create an inclusive, innovative and learning environment where staff and studies/programs will succeed.
- Execute clinical programs in compliance with quality standards (ICH/GCP, Global Regulations, and corporate policies and procedures).
- Strong communication and stakeholder management skills. Is comfortable with not having all the information yet able to drive activities and find solutions to deliver on the program. Qualifications:
- Master's degree or equivalent is required, typically in nursing or scientific field. An equivalent with relevant industry experience is acceptable. 2.5+ years of Pharma-related/ clinical research related experience (and/or applicable work experience) , including approximately 2 years from multinational corporation (MNC).
- Proven ability in leading a global team in the management and completion of multiple, complex clinical studies.
- Ability to demonstrate successful coaching/ mentoring and people management (remote management experience preferred).
- Expertise in Subject Matter and competent in application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance).
- Integral participation in initiatives or advancement strategies for clinical operations.
- Experience in successful study initiation through study completion/primary data analysis in Phase 1-2 with phase 3 preferred.
- Key stakeholder as clinical operations director contributed to successful IND/NDA filing with FDA and CDE health authorities.
- Must possess excellent oral and written English and Chinese communication skills.