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Senior Scientist/Principal Scientist, Clinical Pharmacology

Job Description

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 the classical 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
  • 3y+ 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 skill

Annexon’s Senior Scientist/Principal Scientist, Clinical Pharmacology 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.