Responsibilities:
• Oversee the design and medical/scientific execution of clinical trials from pre-IND onwards to clearly meet program objectives, oversee patient safety, and ensure protocol compliance.
• Provide clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program.
• Lead development of clinical sections of trial and program level regulatory documents.
• Act as a clinical operation director for assigned studies including conducting ongoing reviews of clinical/safety data; collaborates with others in development of case report forms, data management and statistical analysis plans; participates in investigator and other external presentations, meetings and other communications.
• As a clinical expert, supporting function management in interactions with external and internal stakeholders and decision boards.
• Drive execution of the assigned clinical program and/or clinical trial in partnership with Program Leads, functional management, and executive leadership.
o Establishes cross-functional relationships with leaders from key cross-functional lines: Regulatory Affairs, Clinical Operations, Program Management, etc.
o Leverages those relationships to manage key interdivisional interfaces on project issues including but not limited to Research, Development, Manufacturing and Competitive Intelligence
o Leverages functional line expertise to achieve the team goals.
•Supports clinical operations, clinical data management, biostatistics, clinical research organizations (CROs), etc. by acting as a point-of-contact for scientific/medical questions, other communications, and interactions, identifying investigators and sites.