Head of Biomarkers
The Head of Biomarkers is responsible for developing and implementing strategies for clinical biomarkers across the entire Annexon discovery and development portfolio. This strategy is critical to Annexon’s precision medicine approach in the key therapeutic areas of Autoimmune diseases, Neuroscience and Ophthalmology. This individual will serve as an important Annexon leader and integrator between research and development. He/she will also oversee operational aspects such as the collection and analysis of all clinical biosamples and interfacing with external vendors to obtain timely and high-quality data.
• Develop biomarker strategies to enable precision medicine approaches and optimal selection of patient indication and patient subsets in clinical trials.
• Develop biomarker strategy to align the clinical development plan from Phase I to III.
• Supervise biomarker assay development, validation and implementation.
• Lead operations for collection, management and analysis of clinical trial patient biomarker samples.
• Develop biomarker analysis plan and oversee biomarker data analysis; leads the analysis of biomarkers for clinical studies by working with key internal stakeholders and external CROs as needed.
• Provide consultation to pre-clinical programs to drive formulation of biomarker strategy at an early stage of development.
• Responsible for the integration of scientific learnings and clinical biomarker data to define targeted patient populations and enable selection of potential diagnostic platforms.
• Provides expert guidance to multi-disciplinary teams and senior management; act as the Biomarker representative on Project teams.
• Author biomarker strategy documents, biomarker specific portion of clinical protocols, and regulatory documents.
• Use biomarkers to identify opportunities to study compounds in new indications/combinations. • Identify, establish and oversee external collaborations with key opinion leaders, academic sites, and CROs to advance our understanding of disease pathways and prognostic/predictive biomarkers.
• PhD and/or post-doc training in the area of immunology, or other related medical science field with a minimum of 15 years of relevant biotechnology or pharmaceutical industry experience.
• Knowledge of biomarker discovery and development, assay development/validation, clinical discovery of biomarkers, and MoA/translational research.
• Candidate must be detail-oriented with excellent record keeping and organizational skills.
• Must be a highly flexible, results oriented, independent self-starter who enjoys working in a fast-paced and dynamic, team-oriented environment.
• Excellent collaboration, communication, and interpersonal skills are required to engage and be productive within a high achieving team environment.
• Ability to integrate complex scientific ideas, generate testable hypotheses, and execute broad understanding of drug discovery and development in both early and late stage development.
• Familiarity with regulatory approval process.
• Basic understanding of technical aspects of companion diagnostics development
• Proven scientific/leadership expertise (working in teams, managing people/projects commensurate with a senior level).
• Strong experimental background and experience in hypothesis-driven biological/translational research with demonstrated ability to execute well-designed experiments.
Annexon Biosciences is a private, clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, eye and brain. The Company’s pipeline is based on its platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. The Company’s first product candidate, ANX005, is a full-length monoclonal antibody formulated for intravenous administration in autoimmune and neurodegenerative disorders. The Company’s second product candidate, ANX007, is a monoclonal antibody antigen-binding fragment (Fab) formulated for intravitreal administration for the treatment of neurodegenerative ophthalmic disorders. Based on learnings from its initial trials, Annexon is advancing its current programs while evaluating additional orphan and large market indications. Annexon is deploying a disciplined, biomarker-driven development strategy designed to establish that each of its product candidates is engaging the specific target at a well-tolerated therapeutic dose in the intended patient tissue.