Job duties & responsibilities

• Leads the global clinical program development team and is single clinical operations point of contact for assigned clinical development program and related trials on all aspects related to clinical development program strategy, operationalizing the plan, budget development, timelines planning and quality compliance.
• Support the development of various strategic and operational plans such as but not limited to clinical development plan, cross-functional targeted product profile plan, clinical protocol synopsis, full clinical protocol document generation for health authorities (such as US FDA, EMA, UK MHRA, etc.) and respond to questions from health authorities (as applicable), attend Key Opinion Leader (KOL)/partner meetings, give input to the overall project objectives.
• Key partner to cross-functional teams during strategy, planning and execution stage of the clinical program and related trials ensuring that the clinical science and strategy are consistently harmonized with an operationally feasible plan right from pre-IND stage all the way through NDA/BLA/commercial launch and its lifecycle management.
• Empowers the clinical trial team in ensuring that the overall deliverables of the trials are in alignment with the overall development strategy, timelines, budget and quality standards defined by regulations, ICH-GCP, SOPs, working practice guidelines.