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, partnering with strategic vendors and cross-functional teams to ensure timely, high-quality, and within-budget execution of clinical studies. Represents Clinical Operations at the Global Program Team and leads a Clinical Sub Team responsible for the CDP, providing operational oversight of strategic partners and CROs.

• Develop and lead the program-level operational strategy and planning on assigned programs in close collaboration with 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 strategic partners and other vendors to ensure effective execution of clinical studies 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 Global Program Leader and Global Clinical Lead.
• Develop and lead the clinical program operational strategy in collaboration with Clinical Operations Managers, strategic partners, CROs, and other vendors.
• Escalate issues that cannot be resolved at the study level; oversee performance of activities assigned to strategic partners, CROs, and other vendors.
• Manage budget planning and external spend related to clinical program execution; coordinate with COMs, GPM, and Finance to ensure accurate budgets, enrollment, and gaiting.
• Participate in strategic cross-functional initiatives for process and business improvements; communicate program status to enable timely executive decisions.
• Participate in due diligence for business development/in-licensing/alliances as appropriate; provide expert clinical operations input into drug development documents and regulatory meeting preparation.
• Lead or participate in inspection readiness activities and act as subject matter expert during regulatory inspections; drive cross-functional strategic initiatives and process improvements.
• Identify and implement new ways of working more efficiently to meet clinical development needs; model Takeda leadership behaviors and values.

• Education:
  
  Bachelor’s degree or international equivalent required;
  Life Sciences preferred. Advanced degree highly desirable.
• Experience:
  
  10+ years in pharmaceutical industry and/or CRO; 7+ years in clinical study/project management, including early phase (Phase 2 or later) global programs; experience in more than one therapeutic area preferred; strong knowledge of global regulatory and compliance requirements for clinical research (US CFR, EU CTD, ICH GCP) and local country requirements.
• Knowledge:
  Demonstrated excellence in program management, scenario/risk assessment, contingency planning; strong matrix leadership and communication skills; ability to influence without authority; understanding of global regulatory and compliance requirements for clinical research.

• Demonstrated excellence in program management, scenario assessment, risk assessment and contingency planning
• Matrix leadership and communication skills; ability to influence without authority
• Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills
• Entrepreneurial and innovative; willing 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)

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

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