Acerand Therapeutics Ltd (China), located in Shanghai, China, is a start-up pharmaceutical company focusing on Cancer and Autoimmune disease drug discovery research. If you have interest in this position and are determined to make life better for people, please send your CV and contact information to firstname.lastname@example.org
Principal Duties/Responsibilities including but not limited to:
- Provide medical direction into the design of clinical trials. Work closely with other functional areas to facilitate the execution of clinical trials and programs.
- Interpret clinical trial data, and work investigators to develop scientific conclusions from clinical trial data.
- Contribute to the writing review and editing of study-related documents including clinical trial protocols, clinical study reports, IND documents, presentations and manuscripts.
- Serve as a medical monitor for clinical studies, work closely with cross-functional team members to ensure planning and execution of clinical trials to meet key milestones, maintain timelines and keep within agreed budget.
- Serve as lead medical representative with regulatory agencies.
- Play a key role in the development of analysis plans, and in the review, interpretation and communication of clinical trial data from safety and efficacy trials; assist in generating the study reports and publications from these trials.
- Support pre-clinical development planning and translational medicine efforts to effectively advance pipeline programs.
- Provide clinical, scientific and development expertise to business development initiatives as needed.
Education and Experience Requirements:
- MD and PhD preferred or internationally recognized equivalent, medical expertise in Hepatitis required.
- Multiple years of pharmaceutical/biotech-industry experience in clinical research or clinical development, ideally with experience across all phases of clinical trials.
- Possesses thorough understanding of strategic and operational aspects of clinical research and product development.
- Experience in preparation of IND’s and other regulatory documents.
- Excellent ability to lead and work in cross-functional teams with a collaborative style that emphasizes integrity, results, and effective teamwork in a fast-paced and changing environment.