Senior Clinical Project Manager
Not Disclosed•Full-TimeOn-site
location_on4, Hathaway Road, Lexington, Middlesex County, Massachusetts, 02420, United States
About Kiniksa Pharmaceuticals
Kiniksa is a commercial-stage biopharmaceutical company dedicated to developing and commercializing novel therapies for diseases with unmet needs, with a specific focus on cardiovascular indications. Grounded in deep expertise in immunology and inflammation, the company is advancing a growing portfolio of approved and investigational medicines, anchored by ARCALYST®, the first and only FDA-approved therapy for recurrent pericarditis.
At Kiniksa, a highly collaborative, patient-first culture is led by accomplished life sciences leaders. Talented individuals are trusted and empowered to make a real impact, shaping the future of medicine while improving the lives of patients who need it most.
About the Role
The Senior Clinical Project Manager serves as a vital operational expert within the Research and Development function. This role ensures the timely initiation, execution, and reporting of clinical trials in strict accordance with ICH/GCP and all applicable local regulations, supporting product licensure in the United States and global markets.
You will work closely with Program Management, Data Management, Clinical Development, Medical Writing, Biostatistics, Clinical Supply, Global Medical Safety, GCP Quality, and Regulatory staff, as well as Clinical Research Organizations (CROs). The position emphasizes superior execution, transparency within the department and to Senior Management, and the ability to employ cost-effective measures and stewardship regarding clinical trial cost projections and final accounting.
Work Environment
This role is based in our Lexington, MA office and requires employees to be onsite five days per week.
Equal Opportunity Statement
Kiniksa is an Equal Opportunity employer and will consider applicants without regard to race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status. We ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Application Note
Kiniksa does not accept unsolicited resumes from staffing agencies or search firms. Any resumes submitted without a signed agreement will be considered property of Kiniksa, and no fees will be paid.
Work location
Work model: On-site
Similar Job Opportunities
Skills, education and keywords
Skills: Ich/gcp, Edc, Irt, Ind, Bla, Maa, Nda, Ctas, Etd Module 1, Microsoft Office.
Education: Bachelor's Degree in health or biologic science required; Masters-level degree preferred.
Frequently asked questions about Senior Clinical Project Manager at Kiniksa Pharmaceuticals
What does a Senior Clinical Project Manager at Kiniksa Pharmaceuticals do?expand_more
Day-to-day, the Senior Clinical Project Manager at Kiniksa Pharmaceuticals will manage all operational aspects of clinical trials from start-up through database lock; lead cross-functional study teams and partner with cros to ensure timely execution; participate in protocol design, cro selection, site selection, and irb applications; and perform or oversee site monitoring visits for clinical trials as needed.
What are the requirements for this Senior Clinical Project Manager role?expand_more
To qualify for the Senior Clinical Project Manager at Kiniksa Pharmaceuticals position, applicants should have: Bachelor's Degree in health or biologic science; 7 years clinical operations experience; 3 years as clinical study lead or project manager; Global clinical trial experience; Advanced knowledge of Good Clinical Practices; and Working knowledge of FDA regulations for IND clinical trials.
Where is the Senior Clinical Project Manager role at Kiniksa Pharmaceuticals located?expand_more
Senior Clinical Project Manager at Kiniksa Pharmaceuticals is based in 4, Hathaway Road, Lexington, Middlesex County, Massachusetts, 02420, United States. This is a on-site role.