Vice President, Head of Clinical Data Management

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Job Description

Are you looking for a patient-focused company to inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as the Vice President, Head of Clinical Data Management reporting to the Head, Global Integrated Clinical Trial Data Services based in Cambridge, MA.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers and work towards for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

GOALS:

• Establish and drive global data management strategy related to resourcing, technologies and processes to maximize efficiency, innovation and data quality.
• Lead the global data management function to provide data collection, management and integration expertise in support of global development projects and marketed products including all therapeutic areas and business units; ensure functional strategy supports the portfolio priorities.
• Accountable for meeting annual goals, objectives and deliverables for both internal and external Clinical Data Management (CDM) stakeholders.
• Develop, implement and oversee an operational data ownership strategy in support of the global portfolio.
• Liaise with various internal and external groups by forging/maintaining strong partnerships with key stakeholders, e.g., GPTs, regions, Clinical Operations, Data Science Institute (Statistical and Quantitative Sciences, Clinical Data Engineering, Clinical Data Standards), Patient Safety & Pharmacovigilance, and external vendors and CROs for the implementation of data management activities needed for clinical studies across all phases of clinical drug development.
• Provide insight on latest technologies and changes in regulatory environments, enabling emerging priorities and efficient data management leadership for global development programs.
• Lead systematic professional development and provide strong support for direct reports and other members of the Clinical Data Management function.

ACCOUNTABILITIES:

Data management and data integrity oversight:

• Ensure timely and high-quality data management deliverables supporting the Takeda portfolio
• Responsible for Sponsor Oversight of Data Management deliverables and activities performed by Strategic Partners, CROs, other 3rd Party Vendors or FSPs
• Responsible for the reconciliation and cleaning of external vendor data
• Lead implementation of clinical data management best practices (e.g., cross-functional data review, emerging data collection technologies, etc.)

Data Operations and FSP Management:

• Accountable for resourcing algorithms that enable appropriate staffing
• Serve as Subject Matter Expert and data-specific liaison for Process, Training and Compliance and other internal initiatives/projects
• Design and implement clinical data management best practices, ensuring engagement with key stakeholders on critical processes such as cross-functional data review; issue escalation, etc.
• Build and maintain relationship with one or more Functional Service Providers, designed to provide staff augmentation and support build of new and/or improved data management capabilities

Metrics, Analytics and Reporting:

• Lead development of Clinical Data Management metrics, represent CDM function in projects and initiatives related to the reporting and analytics capabilities, including but not limited to R&D Dashboards, Portfolio level performance and productivity and predictive analytics/reporting

EDUCATION & EXPERIENCE:

• BS degree in Computer Science, Life Science or other technical field required, advanced degree desired.
• 15+ years of applicable informatics, systems and /or relevant drug development experience; global experience and experience in drug development strongly preferred.
• 10+ years of data management and leadership experience.
• Senior leadership experience in Clinical Data Management or related field, leading a medium to large organization and influencing executive-level management and key stakeholders.
• Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables.
• Expert knowledge of clinical data management principles, regulations and best practices, as well as common software products and technologies used in drug development.
• Ability to develop and evaluate business cases and effectively manage budgets.
• Knowledge of FDA and ICH regulations and industry standards applicable to drug development systems.
• Knowledge of regulations and best practices related to data collection, electronic records and signatures and data privacy.
• Operational experience in pharmaceutical drug development with significant direct exposure to clinical development.
• 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.
• Demonstrated success in solving complex business problems, strategic thinking, organizational design, leading through periods of significant change, i.e., operating model shifts, company and/or asset acquisitions.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Boston, MA

U.S. Base Salary Range:

$252,000.00 - $396,000.00

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.

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

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time