Director, Medical Monitoring

Kiniksa Pharmaceuticals•Lexington, MA

2d•$286,000 - $316,000•Onsite

About The Position

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.

Requirements

5+ years of clinical development and/or medical monitoring experience in biotechnology and/or pharmaceutical organizations, with an MD degree
Hands-on medical monitoring experience in Phase 2-3 clinical trials
Experience supporting programs through key clinical trial milestones (e.g., study start-up, interim analyses, pivotal study conduct)
Strong ability to integrate clinical, safety, and scientific data into sound clinical and risk-benefit decisions
Solid understanding of global clinical development, GCP, and patient safety requirements
Familiarity with regulatory submissions (e.g., NDA, BLA, MAA) and support of health authority interactions
Comfortable operating as an individual contributor in a lean, dynamic environment
Models transparency, collaboration, and patient-centric decision-making

Nice To Haves

Prior experience as a practicing physician is preferred

Responsibilities

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 TMF
Support preparation for and participate as applicable in site initiation visits and investigator meetings