Executive Director, Program and Study Management, Infectious Diseases and Vaccines

Job Description

Global Clinical Trial Operations (GCTO) is a global organization with over 10,000 people operating in 50 countries. The Program and Study Management organization is a sub-functional unit within GCTO, divided into therapeutic clusters, with approximately 500 people, and is accountable for all operational, technical, and scientific aspects of HQ-sponsored clinical trials, including a grant budget of more than $1B.

• Translate scientific and TA objectives into robust, executable operational strategies for all clinical programs and studies. Guide GCTO teams to understand the competitive landscape, the scientific rationale for development programs, and the long-term vision for assets.

• Full accountability for the operational planning, execution, and delivery of the clinical program portfolio on time, within budget, and with the highest standards of quality.
• Ensure proactive cross-functional collaborations to develop robust trial delivery strategies, assess trial delivery risk each month to bring to GCTO Operational Reviewer and initiate other cross-functional forum to address.
• Execution Excellence – Inspires excellence and drives reliable, high-quality end to end trial delivery through continuous improvement of processes and KPI driven measurement approaches to track progress, identify early risks, and execute mitigations. Provides oversight for all phases of clinical trial management, ensuring performance against key indicators (KPIs) and key quality indicators (KQIs) across domains such as:
• Product and Major Milestone delivery
• Cycle Times:
  Including Time to First Patient In (FPI), Time to Site Ready 80%, Site Activation Time, and Database Lock Time.
• Enrollment, Retention, and Data Quality
• On time, within budget delivery of last patient in (LPI)
• Quality:
  Including Protocol Deviation Rate, Data Entry / Query metrics, Issue Management, eTMF compliance, CV/Org Charts, Training. Drive alignment of CtQ factors at program level.
• Leverage predictive analytics and AI-driven insights to proactively identify, monitor, and mitigate operational risks, ensuring program milestones are met.
• Act as key escalation point for resolving complex operational issues affecting program and study delivery; working across functional leaders to support teams.
• Ensure all activities are conducted in compliance with Good Clinical Practice (GCP), ICH guidelines, and all applicable global regulatory requirements.
• Ensure readiness and leadership for GCD late-stage development reviews, GCTO Ops review, inspections and audits.

• This role is a highly cross functional and influential role within Global Clinical Development. Serve as the key operational partner to Clinical leadership, ensuring GCTO capabilities and strategies are fully integrated to meet the needs of the development pipeline. In turn, champion and represent GCTO needs / operational feasibility.
• Networking & Partnerships - Proactively builds and sustains strategic internal and external relationships to accelerate PSM priorities. Key internal stakeholders include Clinical Scientists, Clinical Directors, Biostatistics, and GCTO Functions.
• Ensure a deep understanding of the science and strategic context of the assigned TAs to inform and challenge operational strategies effectively and to motivate teams.

• Build organizational talent and creates a work environment where teams and individuals can reach their full potential.
• Provide visible, hands-on leadership for a global team of program and study management professionals, fostering a culture of accountability, collaboration, operational excellence, quality and continuous improvement. Empower teams to identify bottlenecks and allocate resources effectively.
• Build and develop a high-performing team through robust on-boarding, continuous education of staff, structured mentorship and people development as well as effectively managing resources. Set clear performance expectations, hold leaders accountable for outcomes and behaviors, and champion the modernization of operations.
• Recruit, resource plan, and build capabilities - including talent reviews, succession planning, and targeted development actions. Sponsor career development pathways that attract, retain and grow talent.
• Champion a positive and inclusive work environment that encourages…