Senior Scientist/Principal Scientist, Clinical Pharmacology

Location
Brisbane, CA
Posted
May 20, 2022
Ref
58603
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

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 withcal 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-researchedcal 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 entirecal 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 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.