Cogent Biosciences
Senior Director, Data Management
Cogent Biosciences, Waltham, Massachusetts, United States, 02254
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 patients.
The Role Senior Director, Data Management
will lead the global Data Management (DM) function across multiple clinical development programs. This role provides vision, leadership, and operational oversight to ensure delivery of high-quality, submission-ready clinical trial data while supporting regulatory, operational, and strategic objectives.
Responsibilities
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
Target Bonus 25% of base salary.
Locations
Waltham, MA – Boston office with collaborative open layout.
Boulder, CO – State‑of‑the‑art research facility in Denver/Boulder corridor.
Benefits Competitive base pay, performance‑based bonus, stock options, and comprehensive insurance coverage (health, dental, life, disability). Competitive time‑off, 401(k) plan, and commuter/parking benefits.
Equal Opportunity Employer We are a proud Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need.
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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 patients.
The Role Senior Director, Data Management
will lead the global Data Management (DM) function across multiple clinical development programs. This role provides vision, leadership, and operational oversight to ensure delivery of high-quality, submission-ready clinical trial data while supporting regulatory, operational, and strategic objectives.
Responsibilities
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
Target Bonus 25% of base salary.
Locations
Waltham, MA – Boston office with collaborative open layout.
Boulder, CO – State‑of‑the‑art research facility in Denver/Boulder corridor.
Benefits Competitive base pay, performance‑based bonus, stock options, and comprehensive insurance coverage (health, dental, life, disability). Competitive time‑off, 401(k) plan, and commuter/parking benefits.
Equal Opportunity Employer We are a proud Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need.
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