Job Description

Key Responsibilities Technical Leadership - Lead and manage the Clinical Trial Transparency team to ensure timely, consistent, and accurate delivery of anonymised documents including full protocols, reporting and analysis plans and clinical study reports to external registers e.g., ClinicalTrials.gov, EU Clinical Trials Register and GSK/ViiV Study Register, and to other national registers, as required. Accountable for: (1) establishing priorities for document anonymisation and ensuring proper controls are in place and (2) operational delivery across the therapy areas by ensuring transparency deliverables meet the requirements of Health Authorities/Regulatory Agencies, Industry Associations, and GSK policy transparency commitments, all of which evolve regularly and maintain robust performance as defined by key performance indicators. Additionally, provide strategic direction and leadership in regulated and policy driven clinical transparency to a team of recognized subject matter experts and manage external resources (outsourced, platforms, consultants) to ensure availability of adequate resources in line with workload needs. Digital Innovation - Lead the thinking and implementation of digital content generation systems using AI/ML within CTT to enhance efficiencies associated with development of disclosure summaries, while ensuring compliance to regulation and quality are met. Support the development of digital dashboards (e.g. Power BI) for measuring CTT KPIs and for tracking CTT deliverables. Build strategies for mini automation projects to carry out routine tasks that will result in improved throughput and better resource utilization. Scientific Business Expertise - Provide strategic direction and leadership in regulated and policy driven clinical disclosures to a team of recognized subject matter experts and management of external resources (outsourced, platforms, consultants) to ensure adequate resources to address workload needs. Cross-functional Stakeholder Management - Partner with and lead interactions with senior management in relevant functional areas. Establish strong relationships with internal business partners (Clinical Sciences, Development Operations, Biostatistics, and Regulatory. etc.) and be the primary contact for all regulated and policy disclosures supporting the entire GSK R&D portfolio. Drive key change management initiatives with these teams to enhance ways of working in line with key organizational goals. Identify ways to continuously create awareness on transparency requirements to stakeholders through the appropriate use of digital communication tools (e.g. informercial videos, bulletins, roadshows, etc.). Process Excellence - Drive the processes for transparency activities leading to timely, accurate and high-quality information posted to public websites. Establish and integrate consistent processes for trial transparency activities throughout the portfolio. Maintain oversight for processes improvement/ efficiencies for the transparency function according to evolving requirements. Bring specialized knowledge of global transparency requirements and standards and provide guidance on best practices to ensure quality of information shared publicly and ensure compliance with defined requirements. Work closely with other roles in CTT (e.g. business capability lead) to strengthen the process knowledge of team members and ensure that written standards and document templates are consistent with changes in regulation/policy or current ways of working, synchronized with global changes in transparency requirements and bring in best practices and standards for transparency. Empower other roles within CTT to function as key enablers of clinical trial conduct by ensuring that regulatory/policy commitments for transparency are met ahead of planned timelines, to support critical organizational initiatives. Industry Benchmarking - Monitor, communicate and proactively plan in response to changes in global Clinical Trial Transparency Regulations including new industry trends and translate into GSK s Clinical Trial Transparency strategy. Maintain GSK initiatives of building trust at the highest standards by continuous adaptation of the internal process to be aligned with the external evolving requirements. Collaborate with other roles in CTT (e.g. benchmarking lead) to identify processes to continually scan the external environment for latest industry trends in transparency. Based on this information, develop processes for authoring of smart disclosure documents that will enable GSK to maintain its industry leading position in transparency, while ensuring that GSK also retains its competitive advantage. Work closely with responsible roles for effective management of Company/Critical Confidential Information in public disclosure documents. Transparency Knowledge Management - Provide medical governance advice in the field of anonymisation on a regular basis to stakeholders across therapy area. Assist trial teams with the collection of required information for postings, answer their questions regarding posting requirements and processes, including recommending resolution or workaround to complex issues, with appropriate consideration of possible impacts. Enterprise Risk Management - Ensure implementation of the risk management framework, including risk identification, assessment and prioritization and the definition of mitigation plans. Design and develop risk mitigation strategies while proactively identifying business transparency risks and implementing strategies to manage the impact of these risks on the business. Business Performance Monitoring - Establish and track key performance indicators that demonstrate compliance with applicable transparency regulations and internal policy. Monitor KPIs for continuous improvement in clinical transparency (e.g. through Transparency Dashboard), including KPIs for oversight of vendors performing the services. Systems and Tools - Integrate disclosure systems with other enterprise systems seamlessly to ensure that information flow is accurate, timely and purposeful. Work closely with disclosure system owners to implement enhancements, improvements and leverage the full functionality of such systems. Lead discussions with owners/stakeholders of complementary business systems to set up efficient networking with the disclosure system to allow for timely availability of information (e.g. study milestones, product approval/termination) that are relevant for transparency teams while also lead the thinking around implementation of new technologies. Cross-functional Governance - Bring specialized and advanced knowledge of disclosure requirements and standards to ensure quality of information shared publicly and ensure compliance with defined requirements. Work closely with the Medical Governance Boards, the Head Medical Governance, Head Publications and the Head Bioethics and Policy to ensure that GSK maintains its industry leading transparency ranking through a robust process for following policy including any exceptions or extensions. Strategic Leadership - Provide strategic direction and leadership in external working groups to develop common principles and standards to support clinical transparency and be a leader for GSK with industry-leading strategies in transparency. Maintain knowledge and expertise in Disclosure environment (Publications ethics and Privacy). Partner with key internal and external stakeholders to strengthen GSK practices for Policy requirements in line with relevant internal and external requirements. Develop strategies involving technology implementation and set targets to match the vision of an organization, creation of future business plans and required actions. Develop teams and partners to work with them by leveraging the synergy of wide variety of talent, while building a capacity that allows rapid implementation of tasks in order to achieve complex or cross-functional objectives. Minimum Level of Job-Related Experience Required Broad scientific/ pharmaceutical industry background with >10 years of experience in clinical research and/or in pharmaceutical industry , of which at least 8 years in Clinical Trial Transparency, Publications or Medical Writing. Extensive experience in Clinical Disclosure, Statistics or Programming with exposure to anonymisation techniques. Proficiency in GCP/ICH guidelines and regulations governing clinical trial disclosure (FDAAA 801 Final Rule, European Clinical Trial Directive, European Clinical Trial Regulation), EMA Policy 70, Health Canada PRCI, GDPR, Privacy Laws, PhUSE, TransCelerate. Knowledge of PhRMA/EFPIA principles and related best practices Experience with Clinical Trial Disclosure software solution(s) Knowledge of GSK clinical/EPI/HE development activities and GCP Guidelines. Proven experience of managing and driving complex transversal projects involving senior management Previous line management experience of 5+ years is essential.