Associate Director, Clinical Operations Program Lead (COPL)

Role Summary

Associate Director, Clinical Operations Program Lead (COPL) leads program-level operational strategy and planning for assigned clinical programs, collaborating with strategic partners and vendors. The role represents Clinical Operations at the Global Program Team, partnering with the Global Clinical Lead to direct the Clinical Sub Team responsible for the CDP, and provides sponsor-level oversight to ensure timely, high-quality, and budget-aligned execution of clinical studies.

Responsibilities

• Develop and lead the program-level operational strategy and planning for assigned programs in collaboration with strategic partners and vendors.
• Represent Clinical Operations at the Global Program Team and partner with the Global Clinical Lead to lead the Clinical Sub Team responsible for the development and execution of the CDP.
• Provide program-level sponsor 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 aligned expectations with the Global Program Leader and Global Clinical Lead.
• Develop and lead the clinical program operational strategy with Clinical Operations Managers, strategic partners, CROs, and other vendors.
• Serve as escalation point for COMs; oversee performance of activities by strategic partners, CROs, and other vendors in collaboration with cross-functional teams.
• Oversee budget planning and external spend related to clinical program execution; collaborate with COMs, GPM, and Finance to ensure budgets, enrollment, and gaiting are accurate.
• Participate in strategic cross-functional initiatives for process and/or business improvements; communicate program status to senior management to enable timely decisions.
• May participate in business development/in-licensing/alliances due diligence from an operational perspective.
• Provide expert clinical operations input into clinical documents and regulatory meeting preparations; lead inspection readiness activities and serve as SME during regulatory inspections.
• Lead or participate in cross-functional strategic initiatives and process improvements; seek new, efficient ways of working to support clinical development.
• Demonstrate leadership behaviors aligned with company values.

Qualifications

• Required: Bachelor’s degree or international equivalent; Life Sciences preferred. Advanced degree highly desirable.
• Experience: 10+ years in pharmaceutical industry and/or CROs, including 7+ years in clinical study/project management; experience in early phase (Phase 1) or Phase 2 or later global programs; more than one therapeutic area desired; knowledge of global regulatory and compliance requirements (US CFR, EU CTD, ICH GCP) and awareness of local country requirements.

Skills

• Demonstrated excellence in program management, including scenario assessment, risk assessment, and contingency planning
• Strong matrix leadership and communication skills
• Able to influence without authority
• Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving abilities
• Entrepreneurial and innovative; willingness to take measured risks and challenge the status quo
• Pragmatic; capable of driving and supporting 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 required travel.