Responsibilities

The Director, Clinical and Translational Development will lead the planning, execution, and oversight of clinical trials and pre-clinical research programs, ensuring alignment with strategic objectives and regulatory requirements. They will design and oversee clinical trial protocols, collaborate with biostatisticians, develop critical clinical documents, and deliver presentations to stakeholders. This role involves overseeing clinical trial management, ensuring compliance with regulatory standards, managing budgets and timelines, mentoring a team, and collaborating with cross-functional teams including R&D, Regulatory, Medical Affairs, and CROs. Furthermore, they will develop and implement clinical and pre-clinical development strategies, oversee regulatory submissions such as INDs and CTAs, and manage interactions with regulatory agencies.