Lead, Third-Party Data Acquisition & Compliance

Takeda Pharmaceutical Co.; Boston (MA); Hybrid; USD 154,000 - 243,000; Full time

Job summary

Takeda Pharmaceutical Co. in Boston, MA is seeking an Associate Director, TPDA to lead third-party data acquisition, ensure data integrity, and drive continuous improvement across the TPDA lifecycle.

The role requires 8+ years in clinical data operations, leadership experience, and strong regulatory knowledge, with a hybrid work arrangement and collaboration across cross-functional teams. The position includes responsibilities for process standardization and vendor oversight.

Qualifications

• BS/BA in health-related, life science, or technology-related fields; MS preferred.
• 8+ years of pharmaceutical/biotechnology drug development experience in clinical data acquisition, management, or related clinical operations roles.
• Prior lead or supervisory experience preferred.
• Strategic knowledge of clinical trial processes, ICH‑GCP and global regulatory requirements, industry standards, and quality control principles.
• Extensive experience managing acquisition, integration, and oversight of external clinical data from third‑party vendors including laboratory data, eCOA, imaging, wearable devices, and emerging data types.
• Excellent project management, organizational, problem-solving, and analytical skills with ability to manage multiple priorities.
• Effective communication and collaboration skills across functional groups in a matrix organization.
• Advanced proficiency with Microsoft Office; experience with TMF systems and clinical data platforms preferred.

Responsibilities

• Oversee TPDA activities for compliance, quality, and audit readiness.
• Oversee day-to-day TPDA operations, prioritization, and quality oversight of deliverables.
• Conduct performance reviews and address performance issues; recruit and develop staff.
• Drive departmental initiatives focused on process improvements, training, standardization, and workflow efficiency.
• Collaborate with cross-functional stakeholders to support study objectives and regulatory compliance.
• Engage with external vendors to ensure service delivery meets quality and compliance standards.

Skills

8+ years pharma/biotech clinical data

Leadership & supervision

ICH-GCP & regulatory knowledge

Project management & analytics

Cross-functional collaboration

Education

BS/BA in life sciences or tech; MS preferred

Tools

Microsoft Office

TMF systems

Clinical data platforms

Job description

Takeda Pharmaceutical Co. in Boston, MA is seeking an Associate Director, TPDA to lead third-party data acquisition, ensure data integrity, and drive continuous improvement across the TPDA lifecycle.

The role requires 8+ years in clinical data operations, leadership experience, and strong regulatory knowledge, with a hybrid work arrangement and collaboration across cross-functional teams. The position includes responsibilities for process standardization and vendor oversight.