Senior Director, Data Management
Who We Are:
Cogent Biosciences is a publicly traded biotechnology company dedicated to developing precision therapies for genetically defined diseases. By leveraging validated biology and a rational drug discovery approach, Cogent aims to create real solutions that address the underlying drivers of disease and offer meaningful hope to patient's.
The company’s lead therapeutic candidate, bezuclastinib, is a highly selective tyrosine kinase inhibitor designed to potently target KIT D816V and other mutations in KIT exon 17. These mutations are known drivers of systemic mastocytosis (SM) and advanced gastrointestinal stromal tumors (GIST) - both serious conditions driven by oncogenic KIT signaling. Bezuclastinib is currently being evaluated in multiple registration-directed trials across Non-Advanced SM (NonAdvSM), Advanced SM (AdvSM), and GIST. In July 2025, Cogent announced that its registration-direct SUMMIT trial in patients with NonAdvSM achieved statistical significance across all primary and key secondary endpoints, and the company is on track to file its first New Drug Application for this patient population by the end of 2025. The company also remains on track to announce top-line results for its APEX trial in patients with AdvSM in the second half of 2025 and for its PEAK trial in patients with GIST by the end of 2025. The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2 inhibitor, and the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting other serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα and KRAS.
Through its commitment to precision medicine and targeted innovation, Cogent Biosciences is working to transform the treatment landscape for patients with serious and underserved diseases. By leveraging validated biology and a rational drug discovery approach, Cogent aims to create real solutions that address the underlying drivers of disease. Our culture of inquisitiveness fuels continuous learning and innovation; we challenge assumptions, ask bold questions, and embrace a mindset of discovery to uncover transformative insights.
The Role:
- Define and implement Cogent’s data management strategy, ensuring alignment with corporate and clinical development goals.
- Represent DM in governance bodies, cross-functional committees, and regulatory interactions, advocating for data quality, efficiency, and compliance.
- Identify and mitigate risks to data integrity, timelines, or regulatory compliance, maintaining inspection readiness.
- Build, develop, and mentor a high-performing DM team across programs and locations.
- Plan resources, manage budgets, and oversee performance for internal teams and outsourced partners.
- Oversee all DM activities across Phase I–IV studies and real-world evidence data collections, including eCRF/CRF design, database setup, data cleaning, coding, data reconciliation, and database locks.
- Develop and maintain Data Management Plans (DMPs), ensuring adherence throughout the study lifecycle.
- Oversee electronic data collection (eDiaries, PRO instruments, and other devices) to ensure scientific objectives are met.
- Establish and maintain global DM standards, SOPs, and best practices in compliance with GCP, CDISC, and regulatory requirements.
- Implement risk-based approaches for data cleaning, review, and validation, driving continuous improvement and process optimization.
- Provide oversight of CROs, EDC vendors, and other external partners to ensure quality, timelines, and cost-effectiveness.
- Coordinate UAT, eCRF build validation, and vendor performance monitoring.
- Partner with Clinical Operations, Biostatistics, Programming, Regulatory Affairs, and Medical Writing to deliver analysis-ready datasets for regulatory submissions.
- Support regulatory submissions (NDA, IND) and inspection readiness by providing DM expertise and guidance.
- Ensure proactive communication across all stakeholders regarding study data, quality metrics, and operational status.
Qualifications:
- Advanced degree in Life Sciences, Computer Science, or related field.
- 12+ years of progressive data management experience in biotech/pharma, with at least 5 years in leadership roles.
- Proven experience managing multiple database locks and leading regulatory submission-ready data initiatives.
- Strong knowledge of clinical trial processes, GCP, CDISC standards, and regulatory requirements.
- Demonstrated experience managing vendor partnerships.
- Excellent communication, strategic thinking, and cross-functional collaboration skills.
- Track record of driving process improvements, operational efficiency, and team development in a fast-paced environment.
Salary Range:
250,000 - 280,000$USD
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