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Reporting to the VP, Clinical Operations, the Sr. Director/Director will ensure that clinical stage programs achieve program objectives within established timelines, budget and quality standards. The Sr. Director/Director will ensure that the appropriate company infrastructure and quality systems are in place to support all clinical trials. In this role, she/he will lead the execution of the clinical studies in conformance with Good Clinical Practices (GCP), International Conference of Harmonization (ICH) Guidelines and Kiniksa SOPs. This role will work closely and collaboratively with Program Management, Clinical, Medical Writing, Biostatistics, CMC, Drug Safety and Regulatory staff as well as Clinical Research Organizations, to ensure the timely execution of studies within budget. Emphasis will be on superior execution, transparency within the department and to Senior Management, and ability to employ cost effective measures and stewardship relative to clinical trial cost projections and final accounting for company.
This role must be based in one of our office locations in Lexington, MA or San Diego, CA. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.
Responsibilities (including, but not limited to):
Qualifications:
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.
Full Time
Pharmaceutical
$132k-172k (estimate)
05/13/2023
04/26/2024
kiniksa.com
LEXINGTON, MA
100 - 200
2015
MICHAEL MEGNA
$10M - $50M
Pharmaceutical
Kiniksa is a biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. We have an experienced team that has advanced multiple product candidates in parallel that focus on a range of debilitating diseases with significant unmet medical need. We continue to explore expanding our pipeline in order to develop life-changing medicines for patients who need it most. We are focused on hiring and retaining a highly skilled team that has extensive experience and ...specific skill sets relating to the selection, development, and commercialization of transformative therapies. Whether in development, research, manufacturing, technical operations, or general / administrative functions, we depend on a brilliant team to support our mission of building a global, generational company. Our benefits are competitive, and we offer dynamic career opportunities across our organization fostering a culture that embraces passion and rapid execution.
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