Associate Director, Clinical Operations Program Lead (COPL)

Role Summary

Associate Director, Clinical Operations Program Lead (COPL) responsible for developing and leading the program-level operational strategy and planning on assigned Clinical Programs in close collaboration with strategic partners and other vendors. Represent Clinical Operations at the Global Program Team (GPT) and partner with the 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 the effective execution of the clinical studies on time, with high quality and within agreed budget. Location: Massachusetts - Virtual.

Responsibilities

• Translate the CDP into an optimal operational strategy and plan. 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 strategic partners, CROs, and other vendors.
• Responsible for budget planning and external spend related to clinical program execution. Work with COMs, Global Program Manager (GPM), and Finance to ensure budgets, enrolment, and gating are accurate.
• Participate in strategic cross-functional initiatives for process and/or business improvements.
• Communicate 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.
• Lead or participate in inspection readiness activities and act 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 leadership behaviors and act as a role model for company values.

Qualifications

• Experience: 10+ years in pharmaceutical industry and/or CRO, including 7+ years clinical study/project management; experience must include early phase clinical studies/Phase 2 studies or later global programs; experience in more than one therapeutic area is highly desired; expertise in global regulatory and compliance requirements for clinical research (US CFR, EU CTD, and ICH GCP); awareness of local country requirements is also required.
• Knowledge: 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.

Skills

• 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)

Education

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