The Director, BioAnalytics will be responsible for managing scientific and technical activities on clinical and preclinical drug development programs.

This role must be based in our Lexington, MA, office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.

Responsibilities (including but not limited to):

• Bioanalytical assay representative for biologics discovery and development project teams
• Act as scientific thought leader, with the ability to apply critical thinking to identify and address emerging issues in collaboration with Research and Clinical Development colleagues
• Apply experience and deep knowledge of bioanalytical methods including potency assays, target engagement and receptor occupancy assays, ADA assays, neutralizing Ab assays and methods for immunogenicity testing, interpretation of PK and immunogenicity data
• Represent bioanalytical/immunogenicity function on clinical stage project teams, manage bioanalytical/immunogenicity aspects of clinical trials at contract research organizations, work closely with clinical colleagues and contribute to clinical study reports
• Leverage bioanalytical assay capabilities to add value and construct a fundamental understanding of the pathway biology and regulation of the drug/target
• Ability to proactively anticipate technical issues that arise during project execution and to consult with management and Project Teams to expedite timely resolution
• Work closely with CROs to maintain quality standards in line with current regulatory requirements; lead in identifying, evaluating and implementing novel technologies to address challenges in drug development

Qualifications:

• Requires a Ph.D. and 10+ years preferred post-Ph.D. in biochemistry, pharmaceutical sciences, biology or related fields with extensive industry experience and track record of solid contributions in preclinical and clinical biologics drug development/pharmacokinetics/immunogenicity
• 8+ years of corporate pharmaceutical industry experience preferred
• Experience in a dynamic and fast paced environment is a plus. Field Knowledge: Advanced knowledge of regulatory, technical and standard industrial practices in bioanalysis for biologics/immunogenicity/pharmacokinetics and a broad knowledge base in drug discovery and development process.Extensive experience in the areas of biologics PK/PD/bioanalytics/immunogenicity and proven track record of contributions and in preclinical and clinical biologics development
• Authorship of bioanalytical, Immunogenicity and PK/TK reports, functional contributions to regulatory documents in support of IND/IB submissions
• Demonstrated experience in working with CROs and managing multiple projects.
• Demonstrated understanding of regulatory requirements and current industry practices in the areas of bioanalytical validation and testing, immunogenicity testing and pharmacokinetics/toxicokinetics
• Demonstrated contributions to clinical candidate advancement and regulatory submissions
• Strategic thinker who can balance near term objectives with long term goals and outcomes
• Strong verbal and written communication skills; ability to clearly articulate scientific viewpoints to a diverse audience
• Ability to thrive in a collaborative team environment

All Kiniksa new hires whose roles require them to enter Kiniksa’s physical offices will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief. Requests for accommodation will be considered on a case-by-case basis, and Kiniksa will consider, among other things whether a proposed accommodation would create an undue hardship.