Immunocore - Rockville, MD
posted 2 months ago
The Associate Director, Clinical Scientist will execute and lead clinical development activities for one or more assigned studies, acting as the leader on assigned study teams and departmental initiatives. This role is critical in contributing to the development of the clinical strategy, which includes developing awareness of the competitive landscape and aligning with the wider company strategy. The position is based onsite and can be located at either of the US locations in Conshohocken, PA or Rockville, MD. In this role, the Associate Director will be responsible for developing the study concept, which encompasses the overall study design, schedule of assessments, objectives and endpoints, and eligibility criteria. They will integrate feedback from various stakeholders, including senior leadership, key investigators, and regulatory agencies. Additionally, the Associate Director will contribute to the authoring of the study protocol and provide critical feedback and review of supporting documents, as well as assist in responding to health authority feedback. The Associate Director will also provide protocol training to internal teams and Contract Research Organizations (CROs), contribute to the design of study-specific case report forms (CRFs), and ensure that CRFs align with study requirements during user acceptance testing. They will oversee real-time clinical data reviews, identifying trends in safety and efficacy data, reviewing Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs), and assessing protocol compliance, escalating issues to the Medical Monitor when necessary. Moreover, the Associate Director will perform analysis and interpretation of clinical data, lead the authoring of selected sections of clinical study reports, and provide expert support and leadership to achieve study and program objectives. They will collaborate with Regulatory and Compliance teams to foster a compliant, high-quality, and inspection-ready culture, adapt to changes in regulatory requirements, and contribute to continuous improvement initiatives. The role may also involve presenting program strategy and results to stakeholders and mentoring clinical science contractors.