Head, Program and Study Management Non-Oncology

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.

• 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.

• 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.

• This role is a highly cross-functional and influential role with Global Clinical…