Annexon Biosciences is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye. 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.
Bioanalytical sciences leads the development, evaluation, and implementation of state-of-the-art bioanalytical methods to support pharmaceutical product development across the Annexon pipeline. These strategies are critical to Annexon’s integrated approach in the key therapeutic areas of Autoimmune diseases, Neuroscience and Ophthalmology. This individual will serve as an important Annexon leader and integrator between preclinical research and clinical development and will apply leading-edge approaches to inform decision-making across the portfolio.
· Accountable for planning, implementation and execution of bioanalytical PK, TE, PD, and immunogenicity assays to inform decision making and regulatory readiness
· Provide scientific leadership and consultation to preclinical and clinical programs across all stages of development to drive formulation of disease- and molecule-specific strategies
· Independently lead and coordinate sample testing, trouble-shooting, and reporting, and/or oversee vendors responsible for this
· Guides the development and execution of stage-appropriate bioanalytical strategies including timelines and resource needs to meet project goals. Scope includes translational nonclinical studies and clinical studies in collaboration with relevant stakeholders such as the research and clinical pharmacology functions
· As a key member of program teams and sub-teams, support collaborative decision-making and achievement of program goals while integrating the bioanalytical sciences perspective
· Support growth, process, and capability development for a growing clinical pharmacology and bioanalytical organization in a dynamic and team-orientated environment
· Author relevant sections of technical reports, regulatory documents, and other documents for internal/external communication
· Compliance with Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) regulations as well as internal/external guidance
· PhD degree or related degree (e.g. MSc / Pharm D) and/or post-doc training in the area of biochemistry, cellular or molecular biology, analytical chemistry, clinical pharmacology, immunology, or other related field with a minimum of 7-10 years of relevant biotechnology or pharmaceutical industry experience.
· Experience across small and large molecule drug development
· Advanced knowledge of assay development, qualification, validation, and regulatory standards for PK, TE, PD, and immunogenicity assays
· Understanding of regulatory approval processes (US and ex-US, IND/CTA and BLA/MAA)
· Must be a highly flexible, results- and detail-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
· Proven scientific/leadership expertise (working in teams, managing internal and outsourced projects)
· Residence in the SF Bay Area is preferred