Director, Clinical Data Standards Governance - Full-time / Part-time

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Job DescriptionAbout the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Director, Clinical Data Standards Governance where you will be responsible for driving the strategy for Takeda’s global data standards, processes, and technologies across the clinical data continuum for quality of deliverables and global data interoperability. You will also actively participate in and influences Data Standards forums (internally or externally) to maintain awareness of any initiatives and trends that could be incorporated into or enhance Takeda's Therapeutic Area Clinical Data Standards Library.  As part of the Data Standards team, you will report to the head of clinical data standards and work with groups across the data science team.

How you will contribute:

• In collaboration with the Clinical Data Sciences Leadership Team and TAU Leaders, establishes and drives strategy of Takeda’s global data standards, processes, and technologies across the clinical data continuum ensuring quality of deliverables and global data interoperability.
• Develops the standards library and ensures proper utilization of standards, adherence to all standards processes, and the timely, thorough assessment of library enhancements and deviations through Standards Governance.
• Builds relationships across the global Takeda organization and CRO partners in support of the standards vision and implementation.
• Has advanced knowledge of all standard library components and metadata across data collection, analysis, and reporting continuum and serves as a resource to support questions raised by regulatory agencies.
• Has a demonstrated understanding of clinical data capture/management systems, clinical databases, data flow, and related infrastructure, with experience in/around EDC, EHR, eCOA, IRT, CDR, MDR, SCE and adjacent systems.
• Has strong working knowledge of clinical study processes and related regulatory requirements or information governance frameworks, (e.g., 21 CFR Parts 11, 312, 314, Good Clinical Practice [ICH-GCP E6 R2], Good Clinical Data Management Practices, HIPAA, GDPR, etc.).
• Supervises staff and vendors developing standards library elements to ensure alignment to standards strategy. Develops training strategy and ensures consistent training program for standards.
• Oversees Standards Governance, manages deviations from standards content and processes, conducts periodic review and development of various metrics including assessment of standards utilization and development trends.
• Drives ongoing development and improvement of industry standards and provides leadership to external professional activities and organizations, such as CDISC, Phuse, Transcelerate, SCDM, EDC users group, SAS users group, etc.
• Actively communicates and ensures compliance with submission standards and guidance documents, regulatory agency expectations and industry trends as applicable to the Takeda organization. Actively participates and contributes at industry standards forums in support of Takeda’s assets.
• Oversees the User Acceptance Testing (UAT) of external data with EDC system and elements related to clinical data standards testing.

Minimum Requirements/Qualifications:

• BS/BA or MS in a life science or analytical area with a minimum of 12-14 years of experience in a CRO/pharmaceutical environment with a proven and consistent record of proactive management and innovation.
• Minimum 12-14 years of clinical data management and/or database or statistical programming experience in pharmaceutical industry or health related field.
• Thorough knowledge and understanding of standards development processes, focused on clinical data with a strong knowledge of CDISC, HL7, OMOP, ICH, ISO standards and an understanding of global privacy regulations.
• Proven track record for development and management of standards library in addition to in-depth knowledge of study design implementation, to define standards eCRFs, edit checks, best practices in EDC and other data acquisition sources.
• Good knowledge of statistical programming languages (e.g., SAS, R, Python, etc.).
• Desirable technical expertise (e.g., Windows NT and UNIX operating systems) and familiarity with common software products and technologies used in conjunction with SAS, familiarity with Rave and/or Veeva.
• Expertise in the requirements and technology required to support electronic data capture and electronic submissions.
• Proven track record in identifying and implementing organization-wide initiatives, standards, and processes.
• Proven track record in managing global, cross-functional standards and processes, support a culture of continual improvement and innovation; promotes knowledge sharing. 
• Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.
• Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenges the status quo.
• Pragmatic and willing to drive and support change and comfortable with ambiguity. 
• Direct experience in the pharmaceutical industry or related field required.
• Previous experience leading a medium to large organization and influencing senior-level management and key stakeholders is a plus.
• Proven track record of leading and driving business process transformation and organizational culture change as well as delivering programs with complex business deliverables.
• Track record of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams. Strong judge of talent with the ability to make tough talent decisions.
• Health care business acumen with a comprehensive understanding of the pharmaceutical industry.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

LocationsCambridge, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time