Takeda · 3 months ago
Associate Director, Clinical Operations Program Lead (COPL)
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
$154K/yr - $241K/yr
10+ years expTakeda is a pharmaceutical company focused on providing better health for people worldwide. They are seeking an Associate Director, Clinical Operations Program Lead (COPL) to develop and lead operational strategies for clinical programs, ensuring high-quality execution of clinical studies in collaboration with various stakeholders. The role involves overseeing program-level operations, budget planning, and participating in strategic initiatives for process improvements.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Develop and lead the program-level operational strategy and planning on assigned programs in close collaboration with our strategic partners and other vendors
Represent Clinical Operations at the Global Program Team (GPT) and partner with Global Clinical Lead to lead the Clinical Sub Team (CST) accountable for the development and execution of the CDP
Provide program-level sponsor’s operational oversight of our strategic partners and other vendors to ensure the effective execution of the clinical studies on time, with high quality and within agreed budget
Accountable to the GPT for the translation of the CDP into an optimal operational strategy and plan. Ensures assessment of various scenarios operational for optimal execution of the CDP. Maintain close communication with the Global Program Leader and Global Clinical Lead to ensure expectations and activities are aligned
On assigned clinical programs, develop and lead the clinical program operational strategy in close collaboration with the Clinical Operations Managers (COMs), strategic partners, CROs, and other vendors
Serve as the point of escalation for the COMs for issues that can’t be resolved at the study level. Collaborate with COMs and cross-functional counterparts to oversee the performance of activities assigned to our strategic partners, CROs, and other vendors
Responsible for budget planning and accountable for external spend related to clinical program execution. Works closely with COMs, Global Program Manager (GPM), and Finance to ensure on a regular basis that budgets, enrolment, and gaiting are accurate
Responsible for participating in strategic cross-functional initiatives for process and/or business improvements
Communicates program status and issues to ensure timely decision-making by senior management
May participate in Business Development/in-licensing/alliances evaluations by providing operational due diligence
Review and provide expert clinical operations input into clinical documents related to the drug development process and into preparation for key regulatory meetings as appropriate
Leads Clinical Operations aspects of inspection readiness activities and acts as subject matter expert during regulatory inspections
Lead or participate in cross-functional strategic initiatives and process improvement
Actively seek new ways of working more efficiently to meet the needs of clinical development
Demonstrate advanced Takeda Leadership Behaviors and act as a role model for Takeda´s values
Qualification
Required
Bachelor's degree or international equivalent required
10+ years' experience in pharmaceutical industry and/or clinical research organization
7+ years clinical study/project management
Experience must include early phase clinical studies/Phase 2 studies or later phase global programs
Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP
Awareness of local country requirements is also required
Demonstrated excellence in program management, including scenario assessment, risk assessment and contingency planning
Demonstrated excellent matrix leadership and communication skills
Able to influence without authority
Excellent teamwork, communication, organizational, interpersonal, conflict resolution and problem-solving skills
Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenge the status quo
Pragmatic and willing to drive and support change
Is comfortable with ambiguity
Embody a culture of continual improvement and innovation; promote knowledge sharing
Fluent business English (oral and written)
Preferred
Life Sciences preferred
Advanced degree is highly desirable
Experience in more than one therapeutic area is highly desired
Benefits
U.S. based employees may be eligible for short-term and/ or long-term incentives.
U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue 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
2026-01-09
2026-01-08
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