Clinical Senior Director

• Responsible for the strategy, direction and execution of clinical development plans including Phase 1 through 3, lifecycle management, medical affairs, safety responsibilities, scientific interactions with regulatory bodies. Ensure clinical development plans are executed on time and within budget. • Oversees tactical development of clinical trial programs, including literature reviews, clinical CRO/investigator selection, protocol development, interpretation of clinical data, and proactive detection of operational issues; proposing operational resolution including protocol amendments. • Identifying strategic issues for therapeutic indications under investigation. Keep abreast of critical evolution of therapeutic options for chosen therapeutic indications and alert Senior Management colleagues and clinical operation staff to evolving management paradigms • Orchestrate and manage clinical aspects of regulatory strategies and interactions with Health Authorities. Review and sign off on all correspondence to Health Authorities as appropriate. Review submission to Ethics Committees, input into responses to any questions/issues raised and support of operational teams. • Interact with KOLs and corporate partner(s) and investors . • Ensure that company practices are compliant with relevant drug regulations. • Build, grow and manage a high-functioning clinical organization with a focus on staff development and appropriate succession planning.