Job Description

We are seeking an experienced and detail-oriented Clinical Research Lead to oversee the planning, execution, and management of clinical trials across all phases (IIV), with a particular emphasis on infectious disease studies. The successful candidate will play a pivotal role in protocol development, regulatory compliance, and cross-functional leadership to ensure the successful delivery of clinical research programs. Key Responsibilities: Lead and manage clinical trials from Phase I through Phase IV, ensuring timelines, budgets, and quality standards are met. Provide scientific and strategic input into clinical trial design, execution, and data analysis. Develop, review, and finalize clinical trial protocols, investigator brochures, informed consent forms, and other essential documents. Serve as the primary point of contact for internal and external stakeholders including investigators, CROs, and regulatory agencies. Oversee site selection, initiation, monitoring, and closeout activities. Ensure compliance with GCP, ICH guidelines, regulatory requirements, and company SOPs. Collaborate with cross-functional teams including regulatory affairs, biostatistics, medical writing, and data management. Monitor and assess study performance metrics and implement corrective actions when necessary. Provide mentorship and guidance to junior clinical team members. Stay current with industry trends, emerging infectious disease threats, and evolving regulatory environments. Qualifications: Advanced degree in Life Sciences (Ph.D, MBBS, MD, Minimum 5–8 years of experience in clinical research, with at least 3 years in a leadership role. Demonstrated experience managing clinical trials in all phases (I–IV) . Strong background in infectious disease clinical studies. Proven expertise in clinical protocol development and regulatory submissions. Excellent organizational, communication, and leadership skills. Ability to work independently and manage multiple projects in a fast-paced environment.