Director, Therapeutic Area Biomarker Lead (Neuroscience)

Major Accountabilities: Accountable for development and implementation of the biomarker strategy for a portfolio of program(s)/disease indication and coordinates biomarker and diagnostics related elements for clinical projects as appropriate in close collaboration with research, development, precision medicine and commercial. Identifies potential project hurdles, provides solutions and establishes contingency plans. Represents Biomarker Development (BMD) on Biomedical Research (BR) or Development project team(s). Responsible for supervising, training, and mentoring of Biomarker Experts, and to ensure line function excellence with respect to administrative efficiency, scientific and technical achievement. Proactively contributes expert biomarker input into key clinical and regulatory documents including clinical study protocols, clinical study reports, investigator brochures, Investigational New Drug application (IND) / Investigational Medicinal Product Dossiers (IMPDs) and New Drug Application/Biologics License Applications within agreed timelines and addresses all regulatory requirements with minimal supervision. Responsible for the biomarker component of study protocols, reports, project summaries and development plans within agreed timelines and which meet regulatory requirements. Prepare appropriate responses to Health Authority questions (globally). Leads/co-leads Translational Data Science Committee (TDSC) and analytical clusters as relevant to their disease areas or asset, oversees biomarker analyses together with the biomarker sub team and integrates, interprets and reports data to project teams and other customers. Leads Biomarker sub-teams and coordinates with appropriate sub-team members and ensures implantation of project strategy and/or prepares summary documentation. Maintains and enhances technical and drug development expertise (e.g. training courses, external meeting attendance), and trains other BMD associates. May act as technical / scientific subject matter expert in key BMD related area. Publishes internally and/or externally as main contributor; patent applications; reviews current literature in own discipline and related areas and proactively shares.