Associate Director, Process Development and Delivery

Associate Director, Process Development and Delivery



Associate Director, Process Development and Delivery

Job ID R0106482 Date posted Sep. 13, 2023 Location Boston, Massachusetts

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Job Description

The mission of the Process, Training and Digital Solutions within Innovation & Data is to drive innovative ways of working to enable a fit-for-purpose clinical trial delivery operating modelWe bring together people, process, data and technology with a focus on continuous improvement to deliver medicines to patients faster.

As the Associate Director, Process Development and Delivery, reporting to the Director of Process Development and Delivery, you will leadactivities for the Clinical Trial DeliveryQuality Management System (QMS) Standard Operating Procedure (SOP) development and maintenance in partnership with R&D Quality Assurance (QA). This includes cross-functional collaboration with stakeholders and functional leaders across R&D.  You will focus on maximizingclinical trial delivery process efficiency and regulatory compliance by leading SOP/QMS document development and overseeing maintenance for supported functional areas with relevant SMEs, senior leadership, stakeholders, and Quality.

The Associate Director, Process Development and Delivery responsibilities include:

  • Advise/strategize with Process Development and Delivery and PTDS leadership on the end-to-end clinical trial delivery GxP document strategy

  • Lead Quality Management System (SOP) development and maintenance process for supported functional areas with relevant SMEs, stakeholders, and Quality; ensure consistency in document portfolio within QMS 

  • Lead the process development and maintenance activities in support the of clinical trial delivery operating model

  • Advise/strategize on the business process owners (BPO)network framework in partnership with PTDS leadership and R&D QA; Oversee facilitation of BPO network (as needed)

  • Maximize clinical trial delivery process efficiency and regulatory compliance by leading process improvement activities and initiatives in global clinical trial delivery functions  

  • Partner with Process, Training and Digital Solutions Innovation & Change Management to develop and manage communications related to process and SOP changes

  • Represent clinical trial process leadership on Quality SOP initiatives 

  • Serve as clinical trial delivery SOP& Process SME for inspections and internal audits; Participate in the development of inspection strategy in collaboration with GCP Operational Excellence

  • Lead QMS system development and maintenance process for supported functional areas with relevant SMEs, stakeholders, and Quality; ensure consistency in document portfolios

  • Ensures consistency and alignment across interdependent processes to provide holistic oversight

  • Lead and/or participate in process efforts for implementation of systems, global initiatives etc.


  • Experience with the pharmaceuticalindustry, including research and development and especially clinical trials conduct. 

  • Deep knowledge and/or experience within clinical trial delivery operations and clinical trial lifecycle

  • Advanced knowledge of drug development and clinical trial processes, including related standards and documents. 

  • Experience leading and/or managing business process owners network

  • Proven conceptual thinking and strategic problem-solving ability

  • Ability to prioritize and lead various team members at various levels to achieve goals

  • Serve as a role model, demonstrating respect and inclusion, creating a culture that fosters innovation

  • Proven ability to adapt to change and manage cultural change in an evolving environment.

  • Work in a global ecosystem (internal and external) with a high degree of complexity including geographically distributed team members and experts with different cultural backgrounds and deep level expertise

  • Ability to build strong relationships and collaborate with other interfacing Takeda functions, including senior leadership

  • Recognize opportunities for improved goals and implement innovative approaches

  • Effectively negotiate and resolve conflicts in a constructive manner

  • Ability to understand highly complex problems and be able to apply effective and innovative solutions to them.


  • BS, MS or equivalent in scientific field

  • Minimum of 8+ years experience in pharmaceutical, CRO, healthcare or related industry

  • Minimum of 3+ years experience with QMS and process development for clinical trial delivery

  • Solid understanding of US CFR, GCP, ICH regulations and the clinical development process

  • Experience in problem solving, negotiations and collaborative team building with non-direct reports and other stakeholders is required

  • Demonstrated ability to positively influence outcomes, key project decisions, and strategic problem-solving 

  • Proven ability to communicate clearly and present key information objectively to all levels of the organization including executive management 

  • Experience in stakeholder relationship management. Influential in orchestrating key stakeholders and project teams to turn vision into reality.

  • Experience with matrix organization, business projects, multi-disciplinary teams or strategic change management projects

  • Extensive experience in design or in implementing solutions and preferable experience in quality improvement.

  • Excellent oral and written communication skills, business acumen, and enterprise knowledge.

  • Work with virtual/agile teams in different locations, aligning and adapting different work, culture, and communication styles.

  • Effectively communicate complex problems and proposed solutions across various levels of the organization

  • Function well under pressure in a changing environment


  • This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy.
  • Base Salary Range: $143,500 to $205,000 . Employees may also be eligible for Short Term and Long-Term Incentive benefits. 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.


Massachusetts - Virtual

Worker Type


Worker Sub-Type


Time Type

Full time


  • Job Type Full time
  • Job Level Senior
  • Travel Minimal

At Takeda, we exist to create better health for people and a brighter future for the world. While we continually evolve science and technology, our ambition remains steadfast — we move science forward so we can transform more lives. The Global Development Office (GDO) maintains a laser focus on Study Management and Site Engagement, Clinical Trial Innovation, Clinical Supply Chain and Patient Safety to ensure absolute quality and enable the predictable delivery of our innovative pipeline.

Through its collaborative process, the GDO team leverages data, digital and analytics to improve speed, quality, performance and predictability within every area of clinical development. We’re building a platform to visualize operational data and enable predictive analytics, while leveraging digital technologies to support clinical supply chain and patient safety. GDO also partners with external organizations and leading academic institutions, such as MIT, to spark innovation in AI and Machine Learning focused on better patient outcomes.

At the heart of GDO are our people: we are committed to building a more diverse, equitable and inclusive culture not only within our own walls and our communities, but also across our clinical trials. It is our passion for people that transforms our work into meaningful action. Come join a team that has earned trust for more than two centuries and advances transformative therapies with honesty, integrity and fairness.

  • Advance clinical research
  • Deliver clinical analytics and study insights using innovative technologies to improve trial accessibility and patient centricity
  • Enable end-to-end management of clinical supply
  • Ensure safety management and inspection readiness

Where You Fit In

As a member of GDO, you will play an important role in bringing forward our rich pipeline of life-changing products to help patients. You will find enriching engagement and a mindset of continuous improvement through creativity, innovation and diversity.

We are a global organization present in the U.S., Europe and Asia with colleagues located in several additional countries to strategically support our business needs. But our people, and the culture they build, are the foundation that sets GDO apart. Our belief in putting people first extends beyond patients. It includes their families and communities, and also our Takeda colleagues and our families.

Working closely with GDO colleagues and key stakeholders across R&D, you will leverage our new operating model and innovative technologies to accelerate the development of our current and future portfolio to bring medicines to patients faster.

One of the main reasons I came to Takeda is because of the people, the people I would be working with, the people I would be working for. We all use PTRB as our north star. I think that makes it easier to delegate decisions and empower each level of the organization to contribute in a meaningful way.

Marisa Rackley Head, Clinical Site Startup & Engagement Global Development Office

It's leveraging technology, it's leveraging data in a very different way. It's not just about using the data that we generate but using real world data and having access to a much more holistic set of data in order to drive the way we work and deliver medicines to patients.

Penny Carlson Head of Innovation and Data Global Development Office

Our Pipeline

Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.

Learn More

What We Believe In

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity ico Integrity
  • Fairness icon Fairness
  • Honesty icon Honesty
  • Perseverance icon Perseverance

Working at Takeda

  • Inclusion

    Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.

  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 15 companies to receive Top Global Employer® status for 2023.

  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

View All Global Development Operations Jobs


We Take Action by Focusing on Our Four Priorities

  • Create an exceptional people experience
  • Responsibly translate science into highly innovative, life-changing medicines and vaccines
  • Protect our planet
  • Unleash the power of data and digital

About our location

Boston, Massachusetts

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