Senior Director, Regulatory Data & Systems Strategy

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Job Description

OBJECTIVES/PURPOSE:

Reporting to the Head, Global Regulatory Information, Data & Systems, the Head of Regulatory Data & Systems Strategy will be responsible for leading the business systems owners, data governance, and data-related enhancements to support Takeda’s regulatory systems.

The Head will be responsible for coordinating regulatory business systems, defining an innovative vision and roadmap, identifying areas for data and capability enhancement, and implementing such initiatives in partnership with R&D DD&T. Further, the Head will be expected to collaborate cross-functionality with business and technical stakeholders, drive partnership with Regulatory Business Operations to drive business prioritization and then work closely with Takeda’s DD&T teams for execution.

ACCOUNTABILITIES:

• Drive the future state vision of regulatory systems at Takeda 

• Collaborate with business process teams, functional SMEs, and others to identify opportunities to enhance regulatory data management  

• Work closely with major platform vendors to understand future state-roadmaps to define opportunities for platform and technology development  

• Leverage inputs from business processes, reporting / analytics, user feedback and other areas to identify areas of continuous improvement 

• Execute data and capability development roadmaps, manage timelines and budget, and collaborate with cross-functional teams to support implementation of enhancements  

• Line management responsibility for up to 10 direct reports 

QUALIFICATIONS:

Educational Qualifications:  

• Minimum BS with 15+ years of experience in Life Sciences or Life Sciences consulting, with a focus on Regulatory preferred  

• Minimum 10+ years of experience with R&D data management, system development, or related experience  

Regulatory Qualifications:  

• Knowledge of regulatory/quality systems relevant to drug development 

• Prior experience with developing and implementing data management enhancements   

• Demonstrates strong skills with increasing independence in regulatory, program management, and technology development, such as understanding broad concepts within regulatory data and implications across the organization and globally; proactively identifies data issues; offers creative solutions and strategies, including risk mitigation strategies. 

• Ability to assess and adapt to the industry’s changing regulations, technology landscape, incorporating learnings into Takeda’s regulatory information management vision  

• Prior experience in leading implementations, working with cross-functional teams, and balancing a technology-forward mindset with business stakeholder needs and requirements  

Interpersonal Skills:  

• Prior experience standing up and leading teams (minimum 5 years of management experience) 

• Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. 

• Must work well with others and within global teams 

• Able to bring working teams together for common objectives.

This position is currently classified as “hybrid” by Takeda’s Hybrid and Remote Work policy

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:

$208,200.00 - $327,140.00

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

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.