Senior Clinical Project Manager

Kiniksa Pharmaceuticals is a commercial‑stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. With deep expertise in immunology and inflammation, Kiniksa is advancing a growing portfolio of approved and investigational medicines, anchored by its lead product, ARCALYST®, the first and only FDA‑approved therapy for recurrent pericarditis. Grounded in rigorous science and bold innovation, the company fosters a highly collaborative, patient‑first culture led by accomplished life sciences leaders. At Kiniksa, 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. The Senior Clinical Project Manager will provide operational expertise within the Research and Development function to ensure timely initiation, execution and reporting of clinical trials in accordance with ICH/GCP and all applicable requirements (including local regulations) to support licensure of products in the United States and global markets.  This role will work closely and collaboratively 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, 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 is based in our Lexington, MA office and requires employees to be onsite five days per week. Responsibilities ( including, but not limited to ): Independently managing all operational aspects for implementation of clinical trial activities from study start-up through database lock, with expertise in accelerating project launch and site start-up / activations, while ensuring adherence to protocol, GCPs and relevant SOPs Leading internal cross-functional study teams and partner with CROs to ensure effective and timely communication, study execution in accordance with the timeline and budget Actively participating in protocol design, CRO selection, site selection and IRB/EC applications for early and late phase clinical studies Managing study-related vendors and serving as the primary point of contact for contracted CROs, study staff and contract labs; identifying potential risks and proactively resolving issues with CROs; establishing vendor management plans and reviewing quality metrics Performing and/or overseeing site monitoring visits for clinical trials as needed Facilitating the timely completion of study protocols (including amendments) and development (and revision) of electronic clinical trial systems (e.g., EDC, IRT) Providing input into and/or developing study related materials such as Clinical Monitoring Plans, Data Management Plans, eCRF forms and completion guidelines, protocols, patient informed consent drafts, site instructions for specimen collections, and study drug order forms Reviewing monitoring reports, protocol deviations and data listings for sponsored studies to ensure reliable quality data are delivered Coordinating with CROs on site selection, IRB submissions, site initiation and close-out planning Managing in a timely and efficient manner all operational aspects of protocol amendments Developing and managing reports for communicating study progress and key metrics to Senior Management and program team Coordinating the negotiation of site budgets within guidelines and providing oversight for site payments per contracts Facilitating site study drug orders, and ensuring full drug chain record management, including site accountability records are maintained; Management of non-drug supply ordering and tracking, as required Providing oversight and ensuring maintenance of clinical trial master files to ensure their compliance with required regulatory and ICH/GCP quality standards and consistency with SOPs Providing input to Drug (IND) filings, Clinical Trial Applications, safety reports, clinical study reports and other ICH compliant sections of registration dossiers (e.g., BLA, MAA, NDA, etc.) Providing oversight of clinical trials to ensure that all adverse events or product safety issues are captured, reported and evaluated by appropriate Clinical personnel in a timely manner Establishing a system and procedure for forecasting (and reforecasting) needs for investigational product for each study and communicating those needs on a routine basis Ensuring inspection readiness and participating with CROs and providing support to sites to prepare for clinical audits/inspections and to respond to audit/inspection findings conducted by internal QA and external regulatory agencies Stand Out Skills for Impact:  Proven leadership in end-to-end clinical trial operations, managing global Phase I–III studies from startup through database lock while ensuring compliance with ICH/GCP and regulatory requirements Strong expertise in cross-functional project and vendor management, leading CROs and internal stakeholders to deliver studies on time, within budget, and aligned to program goals Advanced capability in risk identification, mitigation, and operational problem-solving, driving study execution, site activation, and issue resolution in complex clinical environments Skilled in clinical data quality, regulatory submissions, and inspection readiness, ensuring high-quality outputs, audit preparedness, and contribution to INDs, CTAs, and marketing applications Qualifications and Experience: Requires a Bachelor’s Degree in health or biologic science (BS/BA/ BScN or higher); masters-level degree is preferred A minimum of 7 years clinical operations experience at a sponsor