Assoc. Director, Data Management

Job description

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. Reporting to the Senior Director, Biostatistics, the Associate Director will serve as a strategic data management leader across clinical studies. This role will provide end-to-end leadership from protocol review and study start-up through database lock, regulatory submission support, long-term follow-up, and archival, while ensuring high-quality, analysis-ready clinical data. The Associate Director, Clinical Data Management ensures optimized data collection, flow and access across EDC and non-EDC data sources. 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*):** - Accountable for data management activities for Kiniksa clinical studies and oversee CRO data management activities that support ongoing clinical programs - Review protocols and study strategies to ensure feasible, compliant and effective data collection. - Lead cross-functional data review and align stakeholders on quality, timelines and risk mitigation. - Provides input to improve data processes and organization in alignment with other development functions - Develop and maintain SOPs and working practice documents for data management tasks in collaboration with other functions - Drive study and program milestones, proactively identifying risks and implementing solutions. - Review clinical research documents (eg. Protocols, Case Report Forms, Reports and Statistical analysis) - Lead EDC database (DB) specification process internally and ensure the database is built to capture the protocol schedule and endpoints - Review / Develop DB clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations - Review / Develop Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs - Oversee the User Acceptance Testing (UAT) by CRO and Coordinating UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report - Ensure clinical data within EDC is of high quality to support lock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to data reconciliation and/or coding - Accountable for eDairy, PRO, and other electronic data collection on portable devices to make sure the design of data collection meets the scientific objective - Assist in defining and/or creating data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit - Perform close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBs - Coordinate and communicate with DB vendors on consistent basis to address Clinical team’s requests, project plans, and/or eCRF development activities - Participates in the preparation and presentation of data, when applicable - Ensures data system compliance by following the established guidelines of national and international regulatory authorities - Set up and maintain task related to building database on Medidata URL and generate listings in Clinical data studio tool for data cleaning. - Support regulatory submissions, health authority responses, inspection readiness, and audits. **Standout Skills for Impact:** - Strategic thinking to align data management with long-term organizational objectives - Strong communication skills - Analytical and problem-solving skills to identify data issues and implement solutions - Oversight and leadership to guide teams, manage projects, and ensure adherence to protocols **Qualifications and Experience:** - Requires a Bachelor’s degree or higher (MS preferred) in relevant scientific field or discipline with a minimum of 6+ years of clinical data management experience in pharma/biotech - Proficient in clinical data collection, cleaning and analysis for Phase I- IV clinical trials in a pharmaceutical industry/clinical research company - Experience working in an outsourced data management model - Knowledge of and experience with EDC databases, CDASH/SDTM standards, medical terminology, medical coding dictionaries, and quality control processes - Familiarity with GCP, ICH and FDA requirements as applicable for clinical data management - Prior experience filing a BLA or NDA preferred - Ability to manage multiple initiatives and shifting priorities within a small company environment - Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks. Pay Range $198,000—$210,000 USD Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will 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. 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.