Senior Director Data Management

Senior Director, Clinical Data Management

Company: Commercial-Stage Biotechnology Company
Location: Boston, MA
Employment Type: Permanent

The Opportunity

Brio Resource Group is partnering with a growing biotechnology company with an approved commercial product and an expanding clinical portfolio to identify a Senior Director, Clinical Data Management.

This senior leadership position will provide strategic and operational oversight of Clinical Data Management across development programs and study phases. The successful candidate will lead the function, manage external partners, establish scalable standards, and ensure the delivery of high-quality, submission-ready clinical data.

Key Responsibilities

  • Define and execute the Clinical Data Management strategy across the company’s development portfolio.
  • Provide leadership and tactical direction across clinical programs, projects, and studies.
  • Oversee CRF and eCRF design, database development, edit checks, validation, discrepancy management, data cleaning, and database locks.
  • Develop and implement data management plans, standards, processes, and performance metrics.
  • Evaluate, select, and oversee CROs, FSP teams, EDC providers, ePRO vendors, and other external partners.
  • Ensure timely, accurate, high-quality, and submission-ready clinical data deliverables.
  • Lead process improvements, automation initiatives, and technology enhancements that increase development efficiency.
  • Ensure compliance with internal SOPs, CDISC standards, ICH-GCP, and applicable global regulatory requirements.
  • Partner closely with Clinical Operations, Biostatistics, Statistical Programming, Regulatory Affairs, Safety, and other cross-functional stakeholders.
  • Build and develop the Clinical Data Management function as the portfolio and organization continue to expand.

Qualifications

  • Master’s degree or equivalent in a scientific, healthcare, technology, or related discipline.
  • At least 12 years of progressive Clinical Data Management experience within biotechnology or pharmaceuticals.
  • Demonstrated experience leading Clinical Data Management activities across multiple programs and phases of development.
  • Strong knowledge of clinical databases, EDC platforms, ePRO solutions, data standards, and CDISC requirements.
  • Significant experience managing CROs, FSP teams, and specialized data-management vendors.
  • Comprehensive understanding of ICH-GCP and global regulatory expectations governing clinical data.
  • Proven leadership, team-development, problem-solving, and cross-functional collaboration capabilities.
  • Ability to manage multiple complex programs while anticipating and resolving operational risks.
  • Experience within an emerging or publicly traded biotechnology company is preferred.
  • CNS drug-development experience is beneficial but not required.

Why Consider This Opportunity?

This role offers the opportunity to lead and shape Clinical Data Management within a growing commercial-stage biotechnology company, establish scalable capabilities, and support an expanding development portfolio during an important period of organizational growth.

A complete job description will be provided following an initial résumé review.