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Associate Director, Clinical Biomarkers

Job Description

Company Summary

Annexon Biosciences is a 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.

Desired Candidate Profile

We seek a scientist with extensive experience in Translational Research or Clinical Biomarkers to develop and deliver biomarker strategy for programs in early development. The successful candidate will have the option to lead Neuroscience or Autoimmune franchise. The role will contribute at a broad and strategic level by developing, implementing, and executing on early phase clinical studies applying a modality-agonistic translational approach. Level and compensation will be commensurate with experience.

Responsibilities

  • Develop, establish, and lead efforts aimed at 1) Pharmacodynamics, 2) Patient stratification, 3) Disease relevant biomarkers with association to clinical endpoints.
  • Leads drafting of biomarker-related sections in clinical study-related and regulatory documents (such as clinical protocols, clinical study reports, etc.).
  • Collaborate with Research team to select and implement fit-for-purpose assays based on scientific questions and regulatory requirements.
  • Undertakes cross-functional engagement with Clinical leads, Biomarker and Clinical Operations for implementation of biomarker analyses in the clinic.
  • Manages relationships with external analytical labs, provide input into trial-specific agreements and perform technical assessment of labs involved in biomarker sample analysis.
  • Ensures biomarker sample collections, analyses, data transfers, and reporting are performed in accordance with study protocols and in compliance with regulatory requirements.
  • Responsible for developing and executing biomarker operations plan for clinical studies including scenario planning, assessment of feasibility, forecasting of timelines and resource requirements.

Qualifications

  • Experience and ideally proven record in leading and/or supporting translational strategy of Neuroscience or Immunology programs in clinical development in pharmaceutical and/or biotech environment
  • PhD, PharmD, and/or MD with 5+ years, or Master’s or Bachelor’s Degree with 7+ years of related work experience in pharmaceutical and/or biotech environment
  • Experience designing Clinical Biomarkers strategy. Experience implementing clinical biomarkers in early phase clinical studies desired.
  • Interdisciplinary knowledge of broad biomarker approaches and enabling technologies including fluid, imaging and digital biomarkers
  • Ability to work in matrix-based program teams

Annexon’s Associate Director, Clinical Biomarkers will be required to be fully vaccinated against the Covid-19 virus. An applicant is considered fully vaccinated two weeks after their second dose in a 2-dose series, such as the Pfizer or Moderna vaccines, or two weeks after a single-dose vaccine, such as Johnson & Johnson’s Janssen vaccine. You will be required to show proof of vaccination status upon hire. The Company provides reasonable accommodations in accordance with applicable state, federal and local laws

DIVERSITY, EQUITY, INCLUSION, BELONGING ARE IMPORTANT TO US

We believe that diversity, equity, inclusion and belonging are essential for the strength of our business and the vitality of the communities we serve.

Internally, we want to make sure all employees feel welcome, appreciated and can be themselves at Annexon. We continually educate, inform and hold accountability for improving our diversity, equity, inclusion and belonging efforts. We ensure that open and real dialogue happens on important diversity topics.

Externally, we continuously work to build our pipeline of underrepresented candidates for our workforce, enhance, recruit and develop a best-in-class, diverse, equitable and inclusive workforce; ensure that Black, LatinX and other underrepresented businesses have long-term sustainable opportunities to work with Annexon; and hold our vendors to the same standards under which we operate.

Annexon is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.