Site Engagement Associate Director - Respiratory

GSK•Philadelphia, PA

4d•Remote

About The Position

Through leadership, the Associate Director Site Engagement is accountable for developing, managing, and overseeing long-term and strong relationships with strategically and operationally important Oncology sites and institutions. It includes building and enhancing the image and reputation of GSK with sites locally and providing an interface between GSK and the sites to create an optimal clinical trials environment to generate results in a timely manner with high quality outputs. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Conduct strategic environmental surveillance to anticipate regulatory and operational changes affecting sites and R&D in the United States, and use those insights to design innovative, efficient partnerships. Contribute to the development of a strategic partnership network, acting as the main point of contact between GSK and sites: in the Network SEL will identify external organizations / institutions and evaluate their interest to build and develop networks with GSK on a local basis. Lead the development and expansion of a US site network spanning academic centers, community practices, and emerging site model (hybrid networks, DCT enabled sites. Provide feedback to Leadership, Local Medical Affairs, LOC regarding the development of new partnerships and updates on existing ones Drive performance, by putting in place mutually agreed KPI targets (quality and performance) and organizing regular, periodic performance reviews with the different external partners track compliance with mutually agreed action plans, implementing targeted solutions to reduce cycle times across the study lifecycle and optimize enrolment; participate in/lead site visits to deliver targeted operational support and address site-specific challenges. Work closely with sites and with all members of the LOC Clinical Operations Department to proactively identify bottlenecks at both the study and site level and any risks to quality and compliance and to develop and implement mitigation plans to address these risks, supporting corrective actions to ensure successful outcomes Collaborate with Feasibility, Clinical Operations, and Medical Affairs to drive optimal site placement and study performance Drive adoption of enterprise and other digital and centralized solutions (e.g., eConsent, eReg, remote SIVs, EMR- based identification and remote EMR monitoring access) Conduct an ongoing environmental strategic surveillance and anticipate the legislative and practical evolution of sites and R&D in the country and use those insights to design and curate innovative and efficient partnerships. Give an operational vision of the future GSK clinical research therapeutic areas and GSK portfolio (collaborating with Local Medical Affairs (LOC MED)) to key external stakeholders to anticipate partnerships and to help research institutions and sites better prepare the arrival of clinical trials. Provide strategic input for operational excellence, process efficiency and trial delivery both internally and externally; identify and share best practices at internal cross functional process improvement teams, contributing to efficient and consistent ways of working to optimizing quality and productivity across LOC / region / global site network as appropriate. Consider and develop unique site models, further enhancing portfolio of sites to include in studies

Requirements

Bachelor’s degree in life science or equivalent experience
5+ years’ experience in clinical research operations

Nice To Haves

Ability to travel up to 60% (Domestic)
Experience in respiratory and/or hepatology.
Proficient knowledge of the Drug Development Process
Excellent understanding of the Clinical Study Process, including monitoring
Demonstrated track record of establishing and growing partnerships with strategic sites / institutions

Responsibilities

Conduct strategic environmental surveillance to anticipate regulatory and operational changes affecting sites and R&D in the United States, and use those insights to design innovative, efficient partnerships.
Contribute to the development of a strategic partnership network, acting as the main point of contact between GSK and sites: in the Network SEL will identify external organizations / institutions and evaluate their interest to build and develop networks with GSK on a local basis.
Lead the development and expansion of a US site network spanning academic centers, community practices, and emerging site model (hybrid networks, DCT enabled sites.
Provide feedback to Leadership, Local Medical Affairs, LOC regarding the development of new partnerships and updates on existing ones
Drive performance, by putting in place mutually agreed KPI targets (quality and performance) and organizing regular, periodic performance reviews with the different external partners track compliance with mutually agreed action plans, implementing targeted solutions to reduce cycle times across the study lifecycle and optimize enrolment; participate in/lead site visits to deliver targeted operational support and address site-specific challenges.
Work closely with sites and with all members of the LOC Clinical Operations Department to proactively identify bottlenecks at both the study and site level and any risks to quality and compliance and to develop and implement mitigation plans to address these risks, supporting corrective actions to ensure successful outcomes
Collaborate with Feasibility, Clinical Operations, and Medical Affairs to drive optimal site placement and study performance
Drive adoption of enterprise and other digital and centralized solutions (e.g., eConsent, eReg, remote SIVs, EMR- based identification and remote EMR monitoring access)
Conduct an ongoing environmental strategic surveillance and anticipate the legislative and practical evolution of sites and R&D in the country and use those insights to design and curate innovative and efficient partnerships.
Give an operational vision of the future GSK clinical research therapeutic areas and GSK portfolio (collaborating with Local Medical Affairs (LOC MED)) to key external stakeholders to anticipate partnerships and to help research institutions and sites better prepare the arrival of clinical trials.
Provide strategic input for operational excellence, process efficiency and trial delivery both internally and externally; identify and share best practices at internal cross functional process improvement teams, contributing to efficient and consistent ways of working to optimizing quality and productivity across LOC / region / global site network as appropriate.
Consider and develop unique site models, further enhancing portfolio of sites to include in studies