VP and Head of Operational Effectiveness

GSK•Upper Providence, PA

16h•€190,500 - €317,500•Hybrid

About The Position

As Vice President, Operational Effectiveness, you will be accountable to enable accelerated, compliant and efficient delivery of clinical trial programs and studies across the R&D organisation, by driving operational effectiveness as a source of competitive advantage across Development Operations and the broader R&D organisation. You will ensure that the pillars of performance intelligence, process redesign and planning operate as one connected system and translating the Development Operations rolling three-year strategy into an actionable plan. This will be achieved through process reimagination, continuous improvement in ways of working and systematic capability building — ensuring our people have the skills required to deliver current and future work. The role carries full accountability for articulating value realisation of transformation programs underpinning the Development Operations/R&D strategy, and will architect a performance framework leveraging advanced data and analytics to deliver actionable insights that drive measurable, ambitious improvement in development timelines and operational performance that positions GSK as best-in-class relative to industry peers, accelerating access to medicines and vaccines for patients worldwide. You will also deliver a portfolio of designated operational capabilities (e.g., third-party delivery excellence, documentation/eTMF, project management support, compliance monitoring or other services as scope evolves), establishing fit-for-purpose standards, KPI driven insights and effective risk and issue management to ensure consistent, high-quality outcomes aligned to GSK priorities.

Requirements

Advanced degree in a scientific, business, or operational discipline.
Extensive experience in the pharmaceutical or biotech industry in development, clinical operations or operational excellence.
Excellent understanding of clinical operations processes and ICH/GCP and global regulatory guidelines for drug development and approval processes
Experience designing and leveraging performance frameworks, metrics/KPIs, and data analytics to drive decision-making and improvement.
Experience of leading large-scale transformation or continuous improvement programmes through to measurable value realisation.
Experience in governance and operational management of third-party vendors.
Experience driving the adoption of technology and digital solutions within operational environments.
Demonstrated people leadership to manage and develop people and deliver results.

Nice To Haves

Strong strategic and critical thinking skills, with demonstrated problem-solving, influencing, and decision-making capability at senior levels
Strong business and financial acumen, including experience with business case development and benefit tracking.
Demonstrated cross-functional collaborator with experience in building networks of partners and stakeholders, and broadly engaging with expert communities
Effective communication skills with the ability to communicate and influence at all levels of the organisation, including at RDLT and GLT level.

Responsibilities

Set Strategy and Roadmap for Operational Effectiveness; align to R&D and DevOps priorities and ambitions
Performance Intelligence and Competitive Benchmarking - Provide insights that will drive relevant improvements to set & achieve organizational ambitions and targets: Architect and own a performance framework that maximises data and analytics to improve planning quality, generate actionable insights, and establish metrics/KPIs across Development Operations. Benchmark performance against targets using external peer indicators and competitive intelligence. Diagnose areas of underperformance and design targeted interventions to quantitatively improve program delivery and functional health. Work in close partnership with DevOps Platforms & Innovation (DP&I) to ensure the performance framework is underpinned by robust, integrated data from clinical operations platforms and that insight requirements shape DP&I’s analytics and reporting product roadmap.
Process Reimagination & Future-State Ways of Working: Lead the reimagination and redesign of the end-to-end clinical program and trial operational process landscape and ways of working, aligning them to the Development Operations and R&D future-state vision. Drive the transition from current-state to target operating models, ensuring process changes are embedded, sustained and deliver step-change improvement in speed and quality of delivery.
Transformation Design and Value Realisation: Create the value proposition, lead implementation and achieve and report translatable benefit realisation of priority transformative programs across Development Operations, aligned to the rolling three-year strategy. Accountable for ensuring transformation programs deliver measurable operational improvement rather than activity alone. Define and report transformational outcome metrics (e.g. step-change cycle time reduction, target operating model adoption rates) that demonstrate the impact Development Operations has on the broader R&D organisation.
Capability Building & Culture Transformation: Identify and grow key capabilities across the Development Operations organisation to drive improved performance. Develop training and capability plans that equip teams to adopt new processes, technologies and ways of working. Drive continuous, compliant improvement of cross-functional processes — standardising and simplifying to reduce cycle time and rework and supporting full user adoption of current and emerging technology. Partner with DP&I to ensure capability plans reflect the technology adoption demands of current and future platform deployments. Drive a deliberate culture of innovation, entrepreneurial leadership and continuous improvement across the Operational Effectiveness function and the broader teams it serves. Set the tone for an organisation that challenges the status quo, embraces technology-enabled ways of working and operates with the urgency and accountability required to deliver clinical trial effectiveness at scale.
Operational Excellence for Select Capabilities: Own and strengthen operational excellence, governance, and effective delivery for a portfolio of designated capabilities (e.g., third-party excellence, documentation/eTMF, or other services as needed). Establish fit-for purpose standards, oversight and performance management, enabling transparent KPI-driven insights, effective risk and issue management, and continuous improvement to ensure consistent, high-quality outcomes aligned to GSK priorities. Ensure transformative changes are expertly integrated and organizational ways of working transitioned effectively without disruption to the ongoing clinical portfolio. Capabilities included today but may change as per organizational needs: Third-Party Operational Excellence: Strengthen partnerships and governance of third-party vendors to ensure operational excellence in the delivery of outsourced studies, Functional Service provision and technical vendor deployment. Drive fluid data flow to enable visibility on Key Performance Indicators for all partnerships to enable continuous improvement of third-party delivery to support GSK goals. Design third-party operating models that maximize the value that third parties bring to GSK. Clinical Documentation / Trial Master File Operations: Ensure eTMF and clinical documentation demonstrate compliant execution across all trials. Transition TMF Operations from document collection and archiving to a manner of having controlled information and data available at a fingertip that reconstruct and demonstrate how submission evidence was gathered. Centralised Project Management Support: Provide centralised project management capability supporting Business Development and Research Unit planning needs, ensuring generation of high-quality portfolio data, supporting on time in full execution of the development portfolio, and maintaining resource allocation and delivery standards in alignment with the operating model for Pipeline Project Management across R&D. Compliance: Drive global compliance monitoring and annual monitoring planning. Aggregate country-level compliance insights, feeding risks and trends into process improvement.