Director, Third Party Data Acquisition

GOALS:

• The Director, Third Party Data Acquisition is responsible for timely and high-quality delivery of systems and documentation for non-EDC data in support of Clinical studies. 
• Conduct oversight of implementation, operation, and close-out of Clinical system(s) activities performed by Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives.
• Leader for Third Party Data Acquisition contributes to the management of vendor partnerships to verify contractual assumptions in the study SOWs.  Provides consulting services to Clinical study teams with technology and vendor selection to successfully achieve study goals.

ACCOUNTABILITIES:

• Create and implement standard processes governing end to end data delivery integration activities for EDC, eCOA, eConsent, Telehealth, PK, LAB, BIOMARKER and IMAGING data.

• Oversee creation of training associated with integration activities for EDC, eCOA, eConsent, Telehealth, PK, LAB, BIOMARKER and IMAGING data.

• Knowledgeable in Clinical Data warehouse technologies like MaxisIT CT Renaissance

• Understanding multiple data formats used in technologies like Veeva EDC, Rave or Inform EDC, eCOA, IRT, eConsent, Telehealth.

• Knowledge of clinical data mapping technologies.

• Understanding of Clinical Data Standards to enable data mapping within a system.

• Responsible for identifying gaps and possible improvements to third party data processes to ensure audit readiness and adherence to GCP guidelines. Ensure systems are fit for purpose and ensure all validation activities are thorough, documented and fit for purpose.

• Secures agreements with appropriate stakeholders (including but not limited to Clinical Operations, Clinical Supplies, IT, and Quality organizations) to develop strategies across Clinical Studies in alignment with established Takeda SOPs & Policies, and governance models.

• Manage team of employees and contractors in support of third party data exchange and data integration .

EDUCATION AND EXPERIENCE:

• BS/BA required in a health-related, life science area or technology-related fields, or equivalent combination of education, training and experience.
• MS preferred.
• 10 or more years drug development experience.
• Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
• Strategic knowledge of FDA and ICH regulations and industry standards and quality control principles.
• Extensive experience in acquisition, integration, and management of external clinical data, including laboratory data, pharmacokinetics (PK), ECG, biomarker, imaging, and wearable device data across global clinical trials.
• Proven ability to define and implement data transfer standards and pipelines for multiple third-party vendors, ensuring data integrity, compliance, and alignment with regulatory and business requirements.
• Strong vendor management and business relationship skills, including experience negotiating data agreements, setting KPIs, and overseeing delivery from multiple external data providers.
• Deep understanding of data standards, harmonization, and validation for third-party clinical datasets to enable seamless integration with EDC, Clinical Data Warehouses, and analytics platforms.
• Experience applying System Development Life Cycle (SDLC) principles and change management strategies to adopt new external data sources and technologies, while maintaining compliance with GxP regulations.
• Demonstrated ability to leverage emerging data types and digital endpoints (e.g., wearables, sensors, patient-reported outcomes) to enhance clinical trial insights and decision-making.
• Strong strategic and operational leadership in scaling external data acquisition programs, mentoring cross-functional teams, and fostering a culture of innovation and accountability.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.