Director, Immunology Therapeutic Area Biomarker Lead

Job Description Summary
As an Immunology Therapeutic Area Biomarker Lead (TABL) in the Biomarker Development (BMD) group, you are accountable for defining and delivering biomarker strategies for an immunology portfolio pillar across multiple drug development programs in early and late phase clinical development. In late phase particularly, you will be expected to assume the overall accountability for the biomarker strategy for at least one of our portfolio assets.
You are accountable to translate the pre-clinical mechanistic understanding into an indication-relevant and impactful biomarker strategy, a clinical fit-for-purpose biomarker plan, and oversee the integration into the clinical protocol. You lead the scientific interpretation of biomarker results and strategic discussions in project teams and governance meetings. As such you lead the matrixed Biomarker and Diagnostic teams and are a core member of global project teams to provide scientific, strategic, and tactical leadership on the biomarker strategy and impact.
You are responsible for triaging the early portfolio for biomarker opportunities, training and supporting Biomarker Project Leads. Further you propose, align, and co-chair data science and research initiatives to decipher disease pathology and drug mechanistic understanding.

Job Description

Major Accountabilities

• 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.
• Represents BMD line functions in Therapeutic Area Line Function committees for clinical protocol development and operational milestone reviews.
• Leading overarching asset related biomarker strategies enabling the delivery of late phase assets and respective launch.
• Representing BMD on early and late Disease Area Decision Boards to identify, develop, and drive disease and compound mechanistic biology, clinical decision-making exploratory biomarkers and precision medicine hypotheses for the portfolio.
• Co-leading 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 and responder patient subpopulation identification in clinical trials.
• Providing thought leadership with other BMD TABLs to identify synergies and drive innovation across our large and diverse clinical portfolio in General Medicine.
• Representing BMD line functions in Therapeutic Area Line Function committees for clinical protocol development.
• 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.

Role Requirements

• MD, MD/PhD, or PhD degree required, plus additional PhD/postdoc or equivalent level research.
• Experience in industry (Pharma or Biotech) for at least 5 years in a similar role.
• Scientific excellence in immunological diseases in the translational and biomarker spaces.
• Demonstrated experience leading a mature biomarker strategy to support registration and/or launch.
• 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.
• External leadership/partnership in consortia and/or health authority initiatives
• Scientific excellence supported by recognized high quality publications.
• 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.

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Skills Desired
Accountability, Chemical Biology, Clinical Research, Clinical Trials, Communication, Decision Making, Drug Development, Drug Discovery Process, Immunology, Influence, Influencing Skills, Leadership, Life Science, Medical Research, Mentorship, Molecular Biology, People Management, Professional Presentation, Stakeholder Engagement, Stakeholder Management, Strategic Thinking, Team Management, Well-Being