What are the responsibilities and job description for the Director, Clinical Development position at 89bio?
THE ROLE
Reporting to the Senior Director of Clinical Development , the Director of Clinical Development oversees the management of clinical investigator peer-to-peer interactions in the Phase 3 study, to ensure integrity of late-stage development protocol clinical study design and execution, subject recruitment, safety and study subject retention in the study (ies) . In addition, the incumbent will oversee clinical data collection and analyses. This position is expected to require 50% travel to clinical study sites and professional meetings and will require a solid knowledge of the clinical management and care of patients with metabolic / hepatology disorders
THE RESPONSIBILITIES
- Collaborate with multipdisciplinary clinical team to provide timel y delivery of key global study milestones including patient recruitment and timely completion of late-stage clinical study. Team will include representatives from biostatistics, data management, regulatory, clinical operations, clinical pharmacology and clinical science departments.
- Collaborate with key opinion leaders, principal investigators and clinical scientists to ensure timely study execution through in-person and 1 : 1 interactions, teleconferences, and external committee meetings.
- Collaborate with clinical operations and CRO to identify and manage critical paths and activities, risks, contingencies, and recruitment / retention strategies
- Steer the clinical team members for the planning and execution of the clinical programs in accordance to the product development plans including data management, safety management and medical monitoring plans.
- Communicate program objectives, troubleshoot issues, and resource needs to teams, functional departments, and senior management via routine and ad hoc meetings, minutes, and action items.
- Provide educational support to clinical team on MASH therapeutic area and competitive landscape
- Participate with senior management to establish strategic plans and objectives
- Lead multipdisciplinary and clinical development team to develop new methods and solve complex study challenges.
EXPERIENCE / CAPABILITIES
THE QUALIFICATIONS
