Jobs · OTHR · California

Vice President, Translational Medicine

Annexon Biosciences · San Francisco Bay Area · 1 wk ago
OTHR$310k–$340k/yrFull-time

Responsibilities

  • Translational Medicine Leadership & Strategy
    • Serve as the Translational Medicine Lead across Annexon programs, setting an integrated, portfolio-level strategy that links mechanism of action to clinical outcomes in complement-mediated diseases of the body, brain, and eye
    • Partner with Program Team Leaders, Clinical Development leads, and program teams to define translational hypotheses, proof-of-mechanism and proof-of-concept strategies, and key decision criteria for each stage of development
    • Lead translational prioritization, resource planning, and execution in a fast-paced, dynamic environment consistent with a lean biotech operating model
    • Build and lead a high-performing Translational Medicine organization spanning biomarker science, translational bioinformatics/omics, assay development/operations, and sample/data strategy
  • Biomarker & Evidence Generation (Human Biology)
    • Develop and execute biomarker strategies to demonstrate:
      • Target engagement and pathway modulation (e.g., classical complement pathway/C1q biology)
      • Pharmacodynamic effects and dose/interval rationale
      • Patient stratification and enrichment approaches
      • Disease biology, progression, and treatment response
    • Guide biomarker integration into clinical protocols across neurology and ophthalmology programs, including fluid biomarkers, imaging endpoints, functional measures, and exploratory omics
    • Oversee the development, qualification, and fit-for-purpose validation of translational assays (internal and external), including vendor selection, governance, and quality oversight
    • Lead translational interpretation and integration of multi-modal datasets (clinical, biomarkers, imaging, omics), working closely with Biometrics and Data Sciences to enable actionable insights
  • Program Support Across Flagship and Next-Wave Pipeline
    • Provide translational leadership for:
      • GBS: tanruprubart (ANX005), an IV anti-C1q monoclonal antibody designed to inhibit the classical complement pathway
      • Ophthalmology/GA: vonaprument (ANX007), an intravitreal Fab designed to locally block C1q in the eye while preserving other complement pathway activity
      • Neurodegeneration: programs including Huntington’s disease and ALS leveraging C1q biology and neuroinflammation/synaptic injury frameworks
      • Acute Injury/Functional Decline: programs including traumatic brain injury or myasthenic crisis
      • Autoimmune Neuromuscular: programs including myasthenia gravis, multifocal motor neuropthy, chronic inflammatory demyelinating polyneuropathy (CIDP), and others
    • Ensure translational strategies are aligned with clinical endpoints, regulatory expectations, and differentiation objectives, including competitive landscape awareness and scientific positioning
  • Regulatory, Scientific Communication & External Engagement
    • In collaboration with Regulatory Affairs and Clinical Development, contribute to translational sections of regulatory documents and briefing packages (e.g., IND/CTA updates, BLA/MAA modules as appropriate), supporting robust scientific rationale and biomarker justification
    • Provide scientific leadership and oversight for abstracts, manuscripts, and study reports to ensure quality, integrity, and clarity of translational evidence
    • Represent Annexon for external engagements with KOLs, academic collaborators, consortia, CROs, and scientific meetings; help educate and advance the field regarding Annexon’s approach to classical complement biology
  • Cross-Functional Collaboration
    • Foster strong collaboration and alignment across functions, including Discovery, Translational Sciences, Clinical Development, Clinical Operations, Biometrics, Regulatory Affairs, Medical Affairs, and Commercial
    • Serve as a key liaison between Translational Medicine and executive leadership, providing regular updates on biomarker strategy, human biology learnings, and program implications
    • Cultivate a culture of teamwork, innovation, accountability, and high scientific standards across the translational organization

    Qualifications

    • MD, PhD, or MD/PhD required; advanced clinical/scientific training strongly preferred
    • Minimum of 15 years of experience in pharma or biopharma with leadership responsibility in Translational Medicine, Biomarkers, and/or Clinical Development interfaces
    • Proven track record leading translational medicine organizations (strategy + execution), including building teams, developing biomarker plans, and influencing clinical development decisions
    • Deep domain expertise in one or more of the following required; experience in Immunology/Rheumatology greatly preferred as well as experience across multiple areas:
      • Immunology/Rheumatology (autoantibody biology, complement-mediated disease)
      • Neurology / Neuroimmunology (e.g., peripheral neuropathies, neuroinflammation, neurodegeneration)
      • Ophthalmology (retinal disease drug development; imaging/functional endpoints)
    • Experience partnering with Regulatory Affairs and interacting with regulatory authorities in support of biomarker or translational strategy; experience supporting successful filings is a plus; experience with companion diagnostic development desirable
    • Strong leadership and interpersonal skills, with the ability to inspire and influence cross-functional teams at all levels of the organization
    • Excellent communication and presentation skills, with the ability to clearly articulate complex scientific and clinical concepts to diverse audiences
    • Business acumen and strategic thinking, with a focus on maximizing clinical differentiation and long-term value creation through human biology evidence

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