Summit Therapeutics, Inc. yra biofarmacijos onkologijos bendrovė, kurianti ir komercializuojanti vaistus sunkioms ligoms, kurių gydymo poreikiai dar nėra patenkinti. Pagrindinė jos programa – ivonescimabas (SMT112), bispecifinis antikūnas, veikiantis PD-1 ir VEGF, šiuo metu vertinamas 3 fazės klinikiniuose tyrimuose, skirtuose nesmulkiųjų ląstelių plaučių vėžiui ir kitiems solidiniams navikams gydyti pagal iš „Akeso“ gautą licenciją. Bendrovės veikla apima klinikinį kūrimą, reguliavimo strategiją ir galimą komercializavimą licencijuotose teritorijose, daugiausia dėmesio skiriant gydymui, skirtam pacientams ir jų slaugytojams remti.
Director of Clinical Operations Analytics and Performance Excellence
Lead analytics and performance improvement for global oncology trials at Summit Therapeutics. Oversee Veeva Vault Clinical, data governance, portfolio reporting, and operational excellence.
Jungtinės Valstijos190 000 $ – 237 000 $ / metai
NuotolinisVisas etatasVadovasPrivaloma Kalba: anglųKlinikinės operacijosAprašymas
- Set the Clinical Operations analytics roadmap, including priorities for AI, automation, predictive analytics, and advanced reporting.
- Create portfolio performance frameworks with KPIs, health metrics, scorecards, dashboards, and executive reports.
- Analyze portfolio trends, identify risks, and recommend ways to improve study execution.
- Present portfolio insights and strategic recommendations to senior leaders and executives.
- Oversee Clinical Operations data governance and accountability for operational data quality.
- Act as the Veeva Vault Clinical subject matter expert for CTMS, SSU, and Site Engagement capabilities.
- Define operational data standards across CTMS, SSU, eTMF, and imaging platforms.
- Coordinate with CROs, IT, and vendors on data transfers, analytics and reporting tools, integrations, normalization, and repositories.
- Assess and implement AI-enabled analytics, predictive tools, and automated reporting.
- Lead process and quality improvements using Lean, Six Sigma, or comparable methods.
- Standardize workflows and data governance, improve Veeva Vault Clinical, and guide change management and training.
- Build a data-focused culture and develop a strong team of analytics professionals and business analysts.
- Engage cross-functional stakeholders and turn business questions into analytics requirements.
Reikalavimai
- Bachelor’s degree in life sciences, data analytics, business, information systems, public health, or a related field.
- At least 12 years of experience in Clinical Operations, Clinical Systems, Clinical Analytics, risk-based monitoring, or a related area.
- At least five years of leadership experience managing teams and complex cross-functional initiatives.
- Strong understanding of clinical trial execution and operational metrics.
- Demonstrated experience with Clinical Operations technology platforms and reporting.
- Experience developing executive dashboards and performance management frameworks.
- Strong knowledge of ICH-GCP, regulatory requirements, and inspection readiness expectations.
- Proven ability to lead organizational change.
Privalumai
- Potential bonus
- Stock
- Benefits
- Other applicable variable compensation