Associate Director, Process Development and Delivery
Remote
Associate Director, Process Development and Delivery
Job ID R0106482 Date posted Sep. 13, 2023 Location Boston, MassachusettsBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
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 model. We 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.
CORE ELEMENTS RELATED TO THIS ROLE
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.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS
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
ADDITIONAL INFORMATION
- 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.
Locations
Massachusetts - VirtualWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full time#LI-Remote
- 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.
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 MoreWhat 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.
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Integrity
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Fairness
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Honesty
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Perseverance
Working at Takeda
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Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
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Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission.
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Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
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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.
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Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
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Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
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