Director, Clinical Data Management

Beeline Medicines • Boston, MA

2d • Hybrid

About The Position

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. The Director, Clinical Data Management (CDM) is a senior leadership role responsible for the strategic direction, operational execution, and continuous improvement of all clinical data management activities across the company's pipeline. This is a hands-on, visible leadership position that will shape the data management strategy from the ground up, partnering closely with cross-functional teams within the R&D organization and external partners to advance the company's clinical development programs. Reporting to the Vice President of Biometrics, this individual will establish best-in-class data governance standards, and ensure the integrity, quality, and regulatory compliance of clinical trial data from study startup through database lock and submission. The ideal candidate will bring strong vendor and CRO oversight experience, a commitment to data quality, and the ability to build scalable processes that support a growing pipeline.

Requirements

• Bachelor's degree required in a life sciences, health informatics, computer science, or related field
• Minimum of 10 years of progressive experience in clinical data management within the pharmaceutical, biotechnology, or CRO industry.
• 3+ years’ experience direct vendor management and oversight preferred
• Proven experience managing CDM activities across all phases of clinical development (Phase I–III), including late-stage and/or registration-enabling trials.
• Experience in a lean or early-stage biotech environment, including building CDM functions or infrastructure from the ground up, is a significant advantage.
• Prior experience managing CRO relationships and overseeing outsourced CDM activities at a strategic level.
• Exceptional leadership presence with the ability to influence cross-functional stakeholders, including senior executives, without direct authority.
• Strategic thinker with the ability to translate business and scientific objectives into actionable CDM plans and operational processes.
• Strong project management skills; capable of managing multiple concurrent studies and priorities in a fast-paced, resource-constrained environment.
• Excellent written and verbal communication skills, including the ability to present complex data management concepts to non-technical audiences.
• Demonstrated ability to navigate ambiguity and drive decisions in an evolving, early-stage company environment.
• Collaborative, team-oriented work style with a track record of building productive relationships across functions and with external partners.

Nice To Haves

• Advanced degree (e.g. M.S., M.P.H., or Ph.D.) in a relevant discipline is strongly preferred.
• Experience in immunology or autoimmune therapeutic areas preferred
• Direct experience with global regulatory submissions (IND, NDA, BLA, or MAA) and health authority inspections (FDA, EMA) is strongly preferred.

Responsibilities

• Develop and implement a fit-for-purpose operating model for data management aligned with company goals, including policies, procedures, and best practices for data collection, processing, and review in clinical trials.
• Provide strategic and operational leadership for all CDM functions, including data collection, cleaning, validation, and database lock activities across Phase I–III clinical trials.
• Define and implement the long-term CDM strategy aligned with corporate development goals, regulatory expectations, and industry best practices.
• Serve as the senior CDM representative on cross-functional program teams, contributing to study design, protocol development, and integrated development plans.
• Establish and monitor departmental KPIs, resource plans, and budgets; provide regular status updates to senior leadership.
• Oversee the development and review of key CDM study documents including Data Management Plans (DMPs), Case Report Form (CRF) design specifications, edit check specifications, data validation plans, and database lock checklists.
• Direct the implementation, validation, and management of Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Veeva Vault EDC, Oracle Clinical); ensure systems are fit-for-purpose and validated per applicable regulations.
• Ensure timely and accurate data cleaning, discrepancy management, medical coding (MedDRA, WHO Drug), and reconciliation of external data sources (e.g., central labs, ePRO, safety data).
• Lead database lock activities, ensuring all data quality checks, outstanding queries, and audit trails are resolved and documented prior to lock.
• Manage relationships with external vendors and CROs, including selection, contract negotiation, performance monitoring, and issue resolution to ensure high-quality, timely, and cost-effective data deliverables.
• Oversee the management and quality oversight of CDM activities conducted by CROs and other third-party vendors; review vendor deliverables and hold partners accountable to contractual timelines and quality standards.
• Ensure all CDM activities comply with ICH E6(R2) GCP guidelines, 21 CFR Parts 11 and 312, GDPR, and other applicable global regulatory requirements.
• Lead the development and maintenance of CDM Standard Operating Procedures (SOPs), work instructions, and department-level quality standards; drive adoption across internal staff and CRO partners.
• Partner with clinical, regulatory, and quality teams to integrate data management into study protocols, risk-based monitoring plans, and submission packages; contribute to IND/NDA filings and audit preparations.
• Support regulatory inspections and internal audits; serve as the primary CDM contact for health authority inquiries related to data management practices.
• Ensure data security, privacy (e.g., GDPR, HIPAA), and compliance with global regulations; support regular audits and implement corrective actions as needed.
• Proactively identify data quality risks and implement mitigation strategies; conduct root cause analyses for data issues and drive corrective and preventive actions (CAPAs).
• Perform other duties and responsibilities as assigned

Benefits

• Medical, Dental & Vision insurance (employee premiums 100% covered by company)
• 20 accrued days combined time off (PTO/Sick), 12 company holidays, & winter recharge
• Flexible work arrangements / hybrid schedule
• Health Savings Account (HSA)

What This Job Offers

• Job Type: Full-time
• Career Level: Director