Director - Immunology Therapeutic Area Biomarker Lead (TABL)

Summary

As a Therapeutic Area Biomarker Lead (TABL) in the Biomarker Development (BMD) group, you are accountable for defining and delivering biomarker strategies for the Immunology portfolio across multiple drug development programs in early and late clinical stages. You are accountable to translate the preclinical mechanistic understanding into an indication-relevant biomarker strategy, a clinical fit-for-purpose biomarker plan, oversee the integration into the clinical protocol, and lead the scientific and strategic discussions in project teams and governance meetings. As such you are a key member of global project teams, lead the Biomarker and Diagnostic teams, engage in Translational Data Science teams, and provide scientific, strategic, and tactical input aligned to the portfolio.

In the late phase particularly, you will be expected to assume the overall accountability for the biomarker strategy for at least one of our portfolio assets.

Furthermore, you will be leading overarching asset-related biomarker strategies enabling the delivery of late phase assets and respective launches.

About the Role

Key Responsibilities:

• BMD scientific, strategic and tactical leader at project level driving impactful biomarker strategies and supporting biomarker plan excellence with concise communication in project teams and governance meetings.
• Accountable for the biomarker strategy at a project, indication and study level in coordination with the respective clinical study lead and biomarker study expert.
• Lead a dedicated matrixed group of biomarker subject matter experts and project team representatives to align key stakeholders on the biomarker strategy and biomarker plan at the project and study level and across the portfolio.
• Accountable for the concept, endorsement, implementation, delivery and contextualization of the biomarker strategy.
• Contextualizes biomarker results and disseminates conclusions to external audiences via abstracts and/or peer-reviewed publications.
• Co-leads strategic translational data science working groups focused on integrating large-scale molecular and clinical patient data sets to identify novel indications, patient subgroups, and endpoints to enable decision-making.
• Providing thought leadership with other BMD TABLs to identify synergies and drive innovation across our large and diverse clinical portfolio in immunology and general medicine.
• Representing BMD on early and late Disease Area Initiatives or Consortia to identify, develop, and drive disease and compound mechanistic biology, clinical decision-making exploratory biomarkers and precision medicine hypotheses for the portfolio.
• Implementing strategies in close collaboration with the BMD global organization which includes over 100 associates with expertise in all aspects of biomarker science i.e. genetics, genomics, molecular and cellular, digital devices, imaging and data sciences.

Essential Requirements:

• PhD degree in Life Sciences required
• Experience in industry (Pharma or Biotech) for at least 5+ years, working on Clinical Trials.
• Scientific excellence in immunological diseases in the translational and biomarker spaces.
• Relevant expertise utilizing biomarkers for clinical decision-making including pharmacodynamics, clinical efficacy, disease deconvolution, response characterization, patient stratification and/or precision medicine.
• Evidence of interpreting and disseminating omics related findings, e.g. genetics, genomics, proteomics, with relevant application to clinical decision making while partnering with key stakeholders from research, data sciences and clinical development.
• Scientific excellence supported by recognized high quality publications
• Experience performing similar role within a pharmaceutical/biotechnology research company, clinical research organization or academic medical center
• Proven success in leading and partnering in multidisciplinary matrix teams across pharma/biotech (clinical research through healthcare applications), academic institutions, or commercial business functions.
• Well-developed interpersonal skills with good presence and ability to influence and negotiate with senior leadership, experienced presenter and communicator.
• Fluent in oral and written English; other languages e.g. German, French, Italian useful but not required