Biomarker and Experimental Medicine Leader - Cardiovascular, Metabolism and Immunology

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In Roche’s Pharmaceutical Research and Early Development organization (pRED), we make transformative medicines for patients in order to tackle some of the world’s toughest unmet healthcare needs. At pRED, we are united by our mission to transform science into medicines. Together, we create a culture defined by curiosity, responsibility and humility, where our talented people are empowered and inspired to bring forward extraordinary life-changing innovation at speed.

We are currently looking for a Biomarker and Experimental Medicine Leader (BEML) with a proven track record in leading matrix teams in the design and implementation of biomarker strategies in drug discovery and clinical development to join our Cardiovascular, Metabolism and Immunology (CMI) Discovery and Translational Area within pRED.

• You are a go-to person for biomarker-related activities, working closely with scientists and clinicians to develop biomarker programs for preclinical and clinical stage projects. You lead multidisciplinary biomarker expert teams and you are an individual contributor to global project and clinical expert teams. You are assigned to preclinical portfolio projects as an expert guide for early biomarker deliverables with increasing responsibilities until assuming full accountability for the clinical biomarker strategy up to phase III / approval.

• You integrate input from technical experts to develop, implement and adjust state of the art analytical concepts, recognizing the scientific and clinical basis, the validation status, and the statistical issues related to proposed biomarkers. You are accountable for the interpretation of preclinical and clinical biomarker data and the communication to technical experts, senior leadership, governance bodies, clinical investigators, and health authorities.
  
  You are responsible for biomarker‑specific sections in internal and external documents (incl. study protocols, regulatory, reports, manuals, etc).

• You integrate preclinical, clinical, and real‑world data to guide indication selection and to develop patient enrichment options to increase the probability of clinical success. You design and lead forward and reverse translational research studies and/or projects in collaboration with internal and external partners to support the preclinical and clinical portfolio including prioritization and harmonization of biomarker platforms.

• You stay up to date on novel biomarker modalities and technologies and you are central in the design and implementation of overarching biomarker strategies and capabilities in the Discovery and Translational Area. In addition to advancing our internal portfolio, you are the biomarker lead in Due Diligence teams that evaluate external licensing opportunities and acquisitions.

• You hold a PhD, MD or MD/PhD degree in a relevant scientific field, e.g. cardiovascular, metabolism, immunology, or molecular biology with profound experience and exposure to the discovery and development of biomarkers.

• You have at least 5 years of experience (beyond post‑doctoral training) in drug development and translational research including discovery, development and utilization of biomarkers or biomarker‑technologies, supported by a strong publication record or equivalent contributions.

• You have previous experience supporting clinical studies including the creation and execution of biomarker plans and the successful implementation of internal and external biomarker activities. You have expertise in generating and interpreting data with different sample types and technologies to enable proof of biology, dose selection, and enrichment.

• You have a deep understanding of the mechanisms…