What are the responsibilities and job description for the Senior Director, Data Management position at Cogent Biosciences?
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
Cogent is seeking a strategic and experienced Senior Director, Data Management to 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. The Senior Director serves as the company’s internal DM expert, providing guidance to internal teams, ensuring robust oversight of CROs and external partners, and collaborating cross-functionally to advance clinical development.
Responsibilities
250,000 - 280,000$USD
Target Bonus: 25%
Exact compensation will vary based on skills, experience, and location.
Our Locations
Waltham, MA: Our Boston office includes an open office layout that has recently undergone a makeover designed for collaboration and giving our employees the best work place possible. Free access is provided for both on-site parking and gym facilities in the building.
Boulder, CO: We have just moved into our new state-of-the art Research Facility in the fast-growing biopharmaceutical hub in the greater Denver/Boulder corridor. Our CEO is based full-time in this location and we are proud to call this the home of Cogent’s discovery research organization.
Our Offer To You
To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), competitive time-off, a 401(k) plan, and commuter/parking benefits.
We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. 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.
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
Cogent is seeking a strategic and experienced Senior Director, Data Management to 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. The Senior Director serves as the company’s internal DM expert, providing guidance to internal teams, ensuring robust oversight of CROs and external partners, and collaborating cross-functionally to advance clinical development.
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.
- 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.
250,000 - 280,000$USD
Target Bonus: 25%
Exact compensation will vary based on skills, experience, and location.
Our Locations
Waltham, MA: Our Boston office includes an open office layout that has recently undergone a makeover designed for collaboration and giving our employees the best work place possible. Free access is provided for both on-site parking and gym facilities in the building.
Boulder, CO: We have just moved into our new state-of-the art Research Facility in the fast-growing biopharmaceutical hub in the greater Denver/Boulder corridor. Our CEO is based full-time in this location and we are proud to call this the home of Cogent’s discovery research organization.
Our Offer To You
To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), competitive time-off, a 401(k) plan, and commuter/parking benefits.
We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. 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.
Salary : $250,000 - $280,000