Director, Clinical Development Sciences

**About Beeline Medicines:** Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully. **Job Summary:** The Director, Clinical Data Science is a senior individual-contributor subject matter expert responsible for the quality, integrity, and scientific interpretation of clinical trial data within a therapeutic area of deep specialization. This role partners with clinical operations, biometrics, medical affairs and cross functional R&D colleagues to design and apply bespoke data quality analytics, identify emerging efficacy and safety trends, support real time study execution through the monitoring of collected data, and ensure collected clinical data supports sound scientific and regulatory decision-making. The Director serves as the organization's internal expert on disease-specific endpoints and outcome measures, is recognized internally and externally as a scientific leader in the therapeutic area and works closely with Key Opinion Leaders (KOLs), investigators, and study teams to safeguard data quality from study start-up through database lock and reporting. The role also provides trial design, endpoint, and data strategy consultation to teams advancing novel therapeutic modalities within the therapeutic area. **Work Arrangement & Location:** **Remote** - This position is designated as remote; the incumbent will be expected to travel to Beeline Medicines’ offices on a periodic basis to support in-person collaboration, team engagement, and business operations. The frequency and scheduling of such visits will be determined at the company's discretion based on business need. **Essential Duties and Responsibilities:** - Lead site-, country-, and global-level clinical data quality management across assigned clinical trials, ensuring data integrity from first patient in through database lock; provide data-informed input to site management decisions, including recommendations regarding site retraining or closure based on disease understanding and quality findings. - Develop and maintain bespoke data quality analytics for disease-specific efficacy, safety, and outcome measures, partner with Key Opinion Leaders (KOLs) and study teams to validate methodologies; contribute novel measures that are adopted as data quality standards across the therapeutic area. - Identify data trends and irregularities at baseline and throughout each study; lead root-cause analysis with functional area teams and drive remediation strategies through to resolution. - Provide data-informed input to site management decisions, including recommendations regarding site retraining or closure based on disease understanding and quality findings. - Lead clinical data science input to protocol development, case report form (CRF) design, and site selection; own training materials and functional/quality plan creation; contribute to clinical sections of clinical study reports (CSRs) and program documents (INDs, NDAs/BLAs, CTAs, Briefing Documents, IBs, DSURs, etc.). - Serve as the subject matter expert and internal resource on disease area endpoints and trial design considerations; train and mentor colleagues on relevant measures and quality approaches; recognized internally and externally as a scientific leader in the therapeu…