临床研发总监-泌尿肿瘤

Responsibilities 1. Lead the design and execution of clinical trials in specific areas, ensuring adherence to all applicable regulations, guidelines, and protocols. 2. Act as a medical expert in the therapeutic area of focus, providing guidance and on-hands services on trial design, safety monitoring, PI and CRO communication, and assisting in making clinical development strategy. 3. Collaborate with cross-functional teams, including pre-clinical, CMC, clinical operations, biostatistics, data management, and regulatory affairs, to ensure successful IND approval and trial execution. 4. Review and provide medical oversight of clinical study reports, regulatory submissions, and other documents related to clinical research. 5. Serve as the primary medical contact for investigators, KOLs, CROs, and other external stakeholders involved in clinical trials. 6. Participate in the selection and management of external vendors, including CROs and other third-party providers. 7. Ensure that trial data is properly analyzed, interpreted, and reported in a timely and accurate manner. 8. Stay current with industry trends, developments and trails and apply this knowledge to the design and execution of clinical trials. 9. Foster a culture of innovation and continuous improvement within the clinical research team. 10. Provide mentorship and guidance to junior staff, including other physicians and clinical research associates.

Position requirements: • Medical degree (MD) is required, with board certification in a relevant medical specialty preferred. • At least 7 years of clinical research experience in the pharmaceutical or biotech industry; rich experience in CNS early phase development. • Demonstrated expertise in clinical trial design, execution, and management. • Strong knowledge of applicable regulations and guidelines related to clinical research, including FDA and ICH guidelines • Excellent interpersonal and communication skills, with the ability to effectively communicate complex medical information to a variety of audiences. • Demonstrated ability to work with cross-functional teams and drive project success. • Proven ability to mentor and develop junior staff. • Strong analytical skills and attention to detail. • Experience working with CROs and other third-party vendors. • Ability to travel as needed to support clinical trial activities.

职位描述

职位要求