Associate Director, Clinical Operations Program Lead (COPL)

Role Summary

Associate Director, Clinical Operations Program Lead (COPL) is responsible for leading program-level operational strategy and planning for assigned clinical programs, representing Clinical Operations in cross-functional teams, and overseeing external partners to ensure timely, high-quality, and within-budget execution of clinical studies.

Responsibilities

• Develop and lead the program-level operational strategy and planning on assigned programs in close collaboration with strategic partners and vendors.
• Represent Clinical Operations at the Global Program Team and partner with Global Clinical Lead to lead the Clinical Sub Team for the CDP development and execution.
• Provide program-level sponsor’s operational oversight of strategic partners and vendors to ensure clinical studies are executed on time, with high quality and within budget.
• Translate the CDP into an optimal operational strategy and plan; assess operational scenarios for optimal CDP execution; maintain alignment with the Global Program Leader and Global Clinical Lead.
• On assigned programs, develop and lead operational strategy in collaboration with COMs, strategic partners, CROs, and vendors.
• Serve as escalation point for COMs for unresolved issues at the study level; oversee performance of activities by partners and vendors.
• Plan budgets and manage external spend; collaborate with COMs, GPM, and Finance to ensure accurate budgets, enrollment, and gaiting.
• Participate in strategic cross-functional initiatives for process and/or business improvements.
• Communicate program status and issues to enable timely senior-management decision-making.
• May participate in Business Development/in-licensing/alliances due diligence from an operational perspective.
• Provide expert clinical operations input into clinical documents and regulatory preparation for meetings.
• Lead or participate in inspection readiness activities and act as SME during regulatory inspections.
• Lead or participate in cross-functional strategic initiatives and process improvement; seek efficient ways of working.
• Demonstrate Takeda leadership behaviors and serve as a role model for company values.

Qualifications

• Education: Bachelor’s degree or international equivalent required; Life Sciences preferred. Advanced degree highly desirable.
• Experience: 10+ years in pharmaceutical industry and/or CRO, including 7+ years in clinical study/project management; experience in early phase (Phase 1/2 or global later-phase programs); experience in multiple therapeutic areas preferred; understanding of global regulatory and compliance requirements (US CFR, EU CTD, ICH GCP) and local country requirements.

Skills

• Program management excellence with scenario assessment, risk assessment, and contingency planning
• Matrix leadership and strong communication skills
• Ability to influence without authority
• Teamwork, organizational, interpersonal, conflict resolution, and problem-solving abilities
• Entrepreneurial, innovative mindset; willingness to take measured risks and challenge the status quo
• Pragmatic and adaptable to change; comfortable with ambiguity
• Commitment to continual improvement and knowledge sharing
• Fluent business English (oral and written)

Education

• Bachelor’s degree or international equivalent; Life Sciences preferred. Advanced degree desirable.

Additional Requirements

• Travel: Requires up to 10% travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area travel.