Company Summary

Annexon Biosciences is a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative, and ophthalmic disorders of the body, brain, and eye. The company’s pipeline is based on its platform technology addressing a broad spectrum of well-researched classical complement-mediated autoimmune and neurodegenerative diseases triggered by aberrant activation of C1q, the initiating molecule of thecal complement pathway. Annexon is advancing a portfolio of innovative product candidates designed to block the activity of C1q and the entire classical complement pathway: ANX005 (intravenous administration), ANX007 (intravitreal administration), and ANX009 (subcutaneous administration). Annexon is deploying a disciplined, biomarker-driven strategy designed to improve the probability of technical success of its portfolio.

Desired Candidate Profile

Reporting to the VP, Clinical Pharmacology, we seek a Phd or PharmD with experience leading the design and execution of Clinical Pharmacology and M&S strategies for biologics and small molecules.

Specific Responsibilities

  • Responsible for the design and implementation of the Clinical Pharmacology and Modeling & Simulation (M&S) strategies for biologics and small molecules from pre-IND and FIH studies to pivotal Ph2/3 clinical studies.
  • Apply/guide cutting-edge M&S approaches to ensure development of safe and effective dosing regimens for various patient populations & ensure optimal drug development.
  • Analyze, interpret, summarize and present data to internal project teams, senior management and global health authorities.
  • Develop clinical study designs, study protocols, amendments and reports.
  • Contribute towards development of IND/CTA filings, including BLA/NDA submissions and other regulatory documents.

Key Qualifications

  • PhD in pharmacokinetics or pharmaceutical sciences, or PharmD
  • 6y+ of relevant experience in Clinical Pharmacology in the pharmaceutical industry (level commensurate with experience)
  • Experience in leading the design and execution of Clinical Pharmacology and M&S strategies for biologics and small molecules
  • Excellent critical thinking, scientific and interpersonal skills, including a demonstrated ability to analyze, interpret and report complex PKPD data
  • Proven ability to work/collaborate in a matrix environment and develop relationships with key stakeholders
  • Excellent written/oral communication and presentation skills
  • Annexon’s Clinical Pharmacologist 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.