Director, Medical Monitoring

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 Director, Medical Monitoring, is a key role responsible for ensuring appropriate medical oversight in conducting the study protocol including the integrity of assigned clinical studies in accordance with Good Clinical Practice (GCP). This role operates as a key contributor, ensuring high quality medical review and timely assessments supporting medical decision support and program execution

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):

Provide ongoing medical monitoring oversight for assigned clinical trials, including real-time review of safety data, adverse events, data listings, protocol deviations, eligibility, and laboratory findings to ensure data quality

Serve as a medical point of contact for investigators and sites on eligibility, protocol interpretation, and participant management questions, including providing medical support for routine medical inquiries from internal and external study teams and sites

Engage with investigators, advisors, and external experts to support trial execution and clinical oversight

In collaboration with Global Medical Safety, review and assess adverse events and serious adverse events, including causality assessment, and support safety signal detection in partnership with Pharmacovigilance Provide clinical input into protocol design, amendments, informed consent forms, and other study-related documents

Review and interpret clinical and safety data to inform potential protocol adjustments and trial-level decisions

Develop and maintain medical monitoring plans and safety review processes for assigned studies in collaboration with Global Medical Safety Partner closely with Clinical Operations and CRO on trial conduct, site management, and medical monitoring activities, including leading and supporting discussions with Data Monitoring Committees (DMC)
Partner with Biometrics and Regulatory Affairs to ensure clinical data support statistical and regulatory requirements

Collaborate closely with cross-functional team, including Program Management, Medical Safety/Pharmacovigilance, Regulatory Affairs, Biometrics, Medical Affairs, and CMC teams

Contribute to safety reports, DSURs, and responses to health authority questions

Provide clinical input into briefing documents, responses to regulatory questions, and clinical components of submissions

Document all medical monitoring activities and communications related to assigned studies in TMFSupport preparation for and participate as applicable in site initiation visits and investigator meetings

Standout Skills for Impact:

Clear and credible communication skills with investigators, cross-functional teams, senior management

Ability to anticipate enrollment and endpoint challenges before they arise

Proactive approach in identifying trends early and defining mitigation strategies rather than reacting to problems

Personable ability to build constructive relationships…