Head, Program and Study Management Non-Oncology

Job description

Job Description Global Clinical Trial Operations (GCTO) is a global organization with approximately 10,000 employees operating in 50 countries. The Program and Study Management organization (PSM) is a sub-functional unit within GCTO, divided into therapeutic clusters, and is accountable for operational delivery of the clinical trial portfolio. The Head, PSM is a senior GCTO leadership role responsible for the strategic and operational leadership of a portfolio of clinical programs within assigned Therapeutic Areas (TAs). This role serves as a key and active participant in GCTO Leadership Team (LT) and governance bodies including: GCTO Steering Committee, GCTO Sourcing Governance Committee, GCTO Operations Review, Vendor governance, and GCD Quality & Compliance Council. This role holds single-point, end-to-end accountability for the delivery of all clinical studies within assigned TAs, from initial concept and operational planning through to final reporting and inspection readiness. The Head, PSM will drive enterprise-wide collaboration and ensure seamless integration and strategy alignment with Clinical Development TA and CS Heads, GCTO Functional Leaders, Global Clinical Supplies and other key functions to accelerate high quality delivery of portfolio. Key Responsibilities: 1. Strategic Leadership and Alignment Contribute to the development and execution of the GCTO vision, strategy, and goals, ensuring alignment with the broader company, Research and Development (R&D) and Global Clinical Development (GCD) strategy. Serve as the GCTO point of accountability for the assigned TA(s), partnering closely with GCTO Functions and GCD TA and CS Heads to provide strategic operational input into the overall clinical development plan. 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. 2. End-to-End Program and Study Delivery [Execution Excellence] 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 (e.g. via Product Development Teams, Clinical Sub Teams, deep dives, immersion meetings); assess trial delivery risk each month to bring to GCTO Ops Review trials or initiate other cross-functional forum to address. Execution Excellence – Inspires excellence and drives reliable, high quality delivery by continuous improvement of processes and KPI driven measurement approaches to track progress, identify risks early, and execute mitigations to ensure end-to-end clinical trial delivery. Provide senior 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 the primary 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. 3. Therapeutic Area (TA) Expertise and Collaboration This role is a highly cross functional and influential role with 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. 4. People Leadership and Development Builds 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 cross-functional teamwork, innovation, and professional growth. Provide guidance to line managers on building and leading high-performing teams, managing resources effectively, and developing talent within the function. 5. Operational Excellence and Modernization Champion the modernization of clinical trial operations by identifying and implementing innovative processes, simplification and AI- and Automation-enabled solutions to enable proactive, predictive, and efficient trial management, enhancing overall quality, efficiency and speed. Ensure PSM processes are state of the art, agile and built with quality by design to ensure implementation. Ensure awareness of enterprise initiatives, drive adoption and champion the “why”. 6. Resourcing, Vendor Management, and Financial Stewardship Accountable for the effective planning and management of all resources (headcount and operating budget) for the assigned TA. Drive program-specific vendor strategies building collaborative partnerships tailored to the scientific and operational complexities of the portfolio. This includes providing rigorous oversight of vendor delivery and driving mutual accountability through the continuous monitoring of robust Key Performance Indicators (KPIs) and Key Quality Indicators (KQIs). Actively participate in broader GCD/GCTO-level vendor governance structures while proactively establishing and leading supplementary TA-specific oversight frameworks, as needed to resolve complex escalations, optimize performance, and ensure strategic alignment. 7. External Facing Leadership and Competitiveness Represent the company as a senior operational leader in external forums, including scientific conferences, investigator meetings, and industry consortiums. Build and maintain a strong industry network. Stay abreast of the external landscape, including industry trends, new regulations, and competitor activities, to ensure the company maintains a leading and competitive position in clinical development. Leverage knowledge of industry-wide AI adoption and operational fram