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　　Job Description

　　About 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 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:

　　Supports enforcement of Takeda's Global Data Standards Governance to ensure proper utilization of standards, adherence to standards processes, and the timely, thorough assessment of library enhancements and deviations.

　　Actively leads the identification, review/evaluation, deployment and usage of technologies to generate, distribute, and/or integrate with and report on standards compliance internally, and manages in-house programs along with standards vendor(s) to support Standards Management vision.

　　Builds relationships across the global Takeda organization and with CROs/strategic service providers, provides project management leadership of standards projects and has the ability to partner closely with internal/external standards stakeholders, and serves as a resource to support questions raised by regulatory agencies.

　　Leads and guides key Clinical Data Standards initiatives, including development of work plans, budgets, risk mitigation, and support standards strategies.

　　Contributes as an active member of standards leadership and governance teams:

　　Actively participates in and contributes to the senior leadership team by setting short- and long-term strategies, goals, and tactics.

　　Develops and manages key relationships with teams both within and outside Clinical data standards organization.

　　Demonstrates enterprise leadership and thinking among and across cross-functional partners.

　　Leads cross-functional working teams to:

　　Align plans across the Clinical data standards organization and lead strategic initiatives and planning processes.

　　Facilitate alignment with other business units and functions across Takeda.

　　Ongoing tracking and management of business priorities and initiatives and following up on open tasks related to governance.

　　Minimum Requirements/Qualifications:

　　BS/BA or MS in a life science or analytical area with a minimum of 8-12 years of experience in a CRO/pharmaceutical environment with a proven and consistent record of proactive management and innovation.

　　Minimum of 8-12 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.

　　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.

　　What Takeda can offer you:

　　Comprehensive Healthcare: Medical, Dental, and Vision

　　Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

　　Health & Wellness programs including onsite flu shots and health screenings

　　Generous time off for vacation and the option to purchase additional vacation days

　　Community Outreach Programs and company match of charitable contributions

　　Family Planning Support

　　Flexible Work Paths

　　Tuition reimbursement

　　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 "Hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

　　Base Salary Range: $143,500 $205,000, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

　　The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

　　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.

　　Locations

　　Cambridge, MA

　　Worker Type

　　Employee

　　Worker Sub-Type

　　Regular

　　Time Type

　　Full time