Director, Early Development - Clinical Science

Job description

About the Role The Director, Early Development - Clinical Sciences will create early development clinical plans, program outlines, study designs and clinical study essential documents. This individual will be accountable for leading the cross-functional Study Teams to meet study deliverables and represent clinical development in core team and investigator meetings as needed. This role will collaborate closely with cross-functional teams such as Clinical Operations, Regulatory Affairs, Medical Affairs, CMC, Finance and Legal to drive efficient and scientifically rigorous early development clinical work. Let’s talk about some of the key responsibilities of the role: - Maintains direct ownership of early development clinical deliverables, actively contributing to protocol development, document authoring, data review, study-level problem solving and execution decisions to ensure scientific rigor and operational excellence. - Shape clinical plans including timelines, budgets and oversight of clinical teams. - Author and critically review key clinical and regulatory documents, including protocols, SAPs, CSRs, IBs and clinical value dossiers, ensuring scientific rigor, regulatory alignmen...