About Us
Anokion SA is a clinical-stage biotechnology company that aims to make a meaningful difference in the lives of patients suffering from autoimmune diseases by restoring normal immune tolerance. The company is focused on both prevalent and rare autoimmune diseases, including celiac disease, multiple sclerosis, and type 1 diabetes. Anokion’s distinct approach leverages the company’s immune-based platform, which targets natural pathways in the liver to restore immune tolerance and address the underlying cause of autoimmune disease.
For more information, please visit https://www.anokion.com/ Job Summary
This position is responsible for designing, developing, and utilizing PK and ADA assays for internal studies or CRO transfer. This individual will also weigh in on internal PK study designs and modes of drug administration studies that will help advance preclinical, and clinical programs. The candidate should have a strong working knowledge of PK, ADA, PK/PD principles and TK relationships with application to pre-clinical animal tolerability and efficacy. This position requires strong pharmacometrics skills combined with biological understanding and assay development skills to enable the team to conduct PK modeling studies. The applicant should possess strong communication skills, an understanding of the drug development process, and experience leading from within while collaborating effectively as a member of a cross-functional team.
Responsibilities and Duties
• Owns the assay development and execution of PK and ADA assays while capable of recommending methods, techniques and evaluation criteria for obtaining results
• Communicates effectively PK development progress with project teams while keeping timelines at top of mind
• Collaborates with the broader research team to design and analyze internal mouse PK studies that answer questions relating to mechanism of action
• Works in unison with the development and research teams to evaluate DMPK properties of lead molecules as they relate to modes of administration and molecular design
• Supports non-GLP preliminary animal toxicity studies to enable lead candidate selection
• Provides critical insights into internal PK study designs and modes of drug administration, driving decisions that propel our programs forward
• Capable of working on problems with a diverse scope that requires analysis and data review
• Thinks critically to uncover identifiable factors relating to PK, PK/PD, ADA and TK studies
• Interacts on a technical level with CROs in the areas of PK /ADA assay development, with an eye towards validation, and sample processing
Qualifications
• Candidate should possess strong assay development skills
• Direct industrial experience in the application of PK /pharmacometrics preferably within the context of biologics
• Working knowledge and application of hands-on skills in PK/PD modeling of pre-clinical data
• Experience in conducting TK analysis in support of non-GLP exploratory toxicology studies
• A deep understanding of PK and ADA assay development principles and techniques (ELISA, MSD, BLI, SPR, MS, %recovery) with precision and accuracy
• Thorough comprehension of fundamental PK, ADA, and quantitative pharmacology (PK/PD) principles such as half-life calculations, clearance, Cmax, titers etc.
• Able to work both collaboratively and independently while multi-tasking, prioritizing, and completing assignments in a timely and occasionally accelerated manner
• Adaptable to potential revisions with study designs on a short notice
• Familiarity with PK modeling tools to empower extraction of meaningful insights is a plus
• MS in Pharmacology / Biochemistry or related discipline with 4-6 years of industry (biotech/pharmaceutical) experience or BS with 7-8 years of experience
This role is based on site in Cambridge, MA
Anokion is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law.