Takeda · 6 days ago
Associate Director, Clinical Site Startup and Engagement Process Excellence & Delivery
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
$154K/yr - $241K/yr
7+ years expTakeda is a patient-focused, innovation-driven company transforming the pharmaceutical industry. The Associate Director will be responsible for advancing Clinical Site Startup & Engagement through strategic planning, operational efficiencies, and process optimization.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Works directly with the Head of Process Excellence & Delivery to develop and execute CSSE strategic plans, projects, and commitments to drive operational efficiencies and connectivity across CSSE, Global Development Office (GDO) and Research & Development (R&D)
Assist with building new capabilities for the CSSE organization by becoming a Subject Matter Expert (SME) developing new and/or updating defined standard operating practices (SOPs), guidance documents/job aids, tools, and templates to accelerate transformation towards predictive and agile ways of working
Work with partners and cross-functional colleagues on an enhanced operating model to ensure consistent delivery of global clinical trials by streamlining processes, enhancing systems, and creating effective tools/templates
Support the implementation of process optimization by aligning with business practices set forth by management and continuous improvement initiatives/workstreams becoming a change agent within CSSE, integrating process, and implementing training plans
Drive best-in-class process agility and efficiency, by harnessing innovation to automate data collection and documentation, enhancing compliance, improving quality and robustness of CSSE process
Ensure implementation of new/updated processes and technologies are in compliance with quality standards (including ICH, GCP, local regulations and Takeda SOPs)
Ensure that crucial strategic and operational cross-organizational issues/projects/initiatives are addressed efficiently and track progress of initiatives, working with teams and leaders across R&D functions
Qualification
Required
Bachelor's Degree or international equivalent required; Life Sciences preferred. Advanced degree is highly desirable
7 or more years' experience in the pharmaceutical industry and/or clinical research organization, with demonstrable deep understanding of clinical trial development and delivery process
7 or more years of direct operational experience in pharmaceutical drug development with direct exposure to clinical development (i.e., study management, study startup, country and site feasibility) in a highly matrix organization across multiple regions
Knowledge or FDA and ICH-GCP guidelines for conducting clinical research
Global/international experience required, including ability to collaborate with colleagues and staff in other locations
Experience in people leadership, managing global teams, change management and coordinating collaboration with cross-functional teams
Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables
Strong strategic thinking, planning, execution, and communication skills
Health care business acumen with a comprehensive understanding of the pharmaceutical industry
Benefits
Short-term and/ or long-term incentives
Medical, dental, vision insurance
401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
Tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
2026-01-14
Pharmaceutical Technology
2026-01-11
Company data provided by crunchbase