Senior Director, Design & Delivery, Development & Regulatory (Hybrid)

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Job Description

Objective / Purpose:

The Head of Design & Delivery, Development & Regulatory will lead the global technical product strategy across Takeda’s development technology portfolio, encompassing Clinical Development, Regulatory Affairs, and Pharmacovigilance domains.

This role is accountable for shaping and delivering innovative, compliant, and business-aligned digital solutions across the development lifecycle — from protocol design through regulatory submissions to post-market safety surveillance. You will lead a global team of product managers and work cross-functionally to ensure that Takeda’s development technology platforms are modern, scalable, and enable faster, safer delivery of medicines to patients.

Accountabilities:

• Define and execute the strategic product roadmap across Development Technology domains, in support of the R&D DD&T Strategy, including: Global Development Technologies (CTMS, EDC, eTMF, IRT, eCOA, DCT solutions). Regulatory Affairs Technologies (RIM systems, publishing tools, global submission management, labeling platforms, IDMP readiness). Pharmacovigilance Technologies (safety databases, signal detection, case processing automation, E2B compliance).

• Ensure platforms are integrated, compliant, and user-centric across all business areas.

• Build, mentor, and lead a high-performing global product management team. Foster a product-driven culture grounded in Takeda’s values: Patient–Trust–Reputation–Business.

• Collaborate with senior leaders across GDO, GRA, PSPV, and IT delivery to align technology strategies with evolving business needs.

• Identify and integrate emerging technologies (e.g., automation, AI/ML, NLP, digital submissions, real-time safety monitoring) into the product portfolio to drive operational excellence and innovation in Regulatory and PV functions.

• Ensure all products are developed and maintained in compliance with global regulations (e.g., GxP, 21 CFR Part 11, ICH, EMA, FDA, PMDA) and Takeda’s quality and risk management standards.

• Work closely with architecture, engineering, quality, and data teams to ensure scalable and interoperable solutions across R&D.

• Represent Development Technology product leadership in strategic governance forums, investment planning committees, and external regulatory or industry working groups as needed.

• Ensures alignment of product solutions to Takeda’s short and long-term goals, both tactical and strategic.

• Leads and mentors POD Owners, Technical Leads, Business Analysts, and Quality Engineers, fostering a collaborative and high-performing environment.

• Provides guidance and coaching to team members and teams, reviewing and assessing team performance and identifying areas for improvement.

• Responsible for stakeholder management, driving cross-functional collaboration and communication to ensure smooth project/product delivery and alignment with stakeholder expectations.

• Handles risk management, identifying potential project/product risks and implementing mitigation strategies.

• Oversees project budgets, resource allocation, and timelines to ensure timely delivery of projects within budget and in adherence to quality standards.

• Performs other related duties as assigned.

Education & Competencies (Technical and Behavioral):

Required:

• Bachelor’s degree in Life Sciences, Information Technology, Engineering, or a related field; advanced degree (e.g., MBA, MS) strongly preferred.

• 12+ years of experience in pharmaceutical R&D technology or digital product leadership roles, with deep expertise across Clinical, Regulatory, and Pharmacovigilance domains.

• Strong understanding of global regulatory and safety compliance requirements and technologies supporting submissions, labeling, safety surveillance, and data traceability.

• Demonstrated ability to lead product teams through complex, regulated environments using modern product management and agile delivery frameworks.

• Strategic thinker with outstanding leadership, communication, and stakeholder engagement skills.

• Proven success managing global teams, product portfolios, and vendor ecosystems.

• 7 years of experience in a leadership role within a technology or product development environment.

Preferred:

• Master’s degree in Information Technology, Business or a related field.

Technical Competencies:

• Familiarity with technology platforms such as Veeva Vault RIM and Safety, Argus, Veeva Clinical, TrackWise, Medidata, and/or modern safety signal detection and automation tools.

• Experience with regulatory intelligence, IDMP, structured content authoring, and data standardization initiatives.

• Passion for transforming development operations through ethical, patient-centered innovation.

• Knowledge of current industry trends and emerging technologies within the R&D Pharmaceutical and Pharmaceutical Sciences sectors.

• Knowledge of principles and methods for defining and structuring field-relevant topics, including the ability to adapt research methods to the appropriate domain.

• Ability to propose and prioritize future research directions, assessing trade-offs between technical risks and potential benefits/rewards.

• Knowledge of product areas and key trends associated with them.

• Knowledge of project management principles and methodologies with a proven track record in delivering complex technology projects.

Behavioral Competencies:

• Ability to thrive in a dynamic environment.

• Experience with prototyping tools and techniques.

• Demonstrated verbal and written communication, presentation, and negotiation skills.

• Ability to manage and influence a variety of stakeholders at all levels.

• Demonstrated problem-solving skills, with the ability to work effectively under pressure and adapt to changing priorities.

• Ability to manage financial and people resources across multiple business functions, portfolios, and projects.

• Ability to understand customer and/or partner needs through dialogue before recommending solutions.

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

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