GlaxoSmithKline Director Clinical Programming in Philadelphia, Pennsylvania
Director Clinical Programming
Open date:Apr 12, 2018 9:20 AM
Functional area:Medical and Clinical
Experience required:Not Indicated
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Your Responsibilities:GlaxoSmithKline is one of the world's leading pharmaceutical and healthcare companies, with statisticians and programmers working in Research and Development at UK, US and India sites. The Quantitative Sciences division includes a Clinical Programming department, sitting within the broader Clinical Statistics group, covering all phases of clinical drug development and commercialisation in a wide range of therapeutic areas. In recognition of the developing sophistication and technical requirements of the role, Clinical Programming was formed as a standalone department distinct to Clinical Statistics about 3 years. In addition to the group’s activities supporting GSK’s pipeline of drugs, key accountabilities include developing and implementing strategies for programming resourcing using both internal, external, onshore and offshore resource; driving CDISC implementation for the reporting of clinical trials; and identifying and implementing IT solutions to offer further benefit and efficiency for the group’s activities.
These are high profile roles, with global leadership opportunity within our Quantitative Sciences business. Candidates should have expertise in one of the following areas: Respiratory, Oncology or Immuno- Inflammation
• Oversees programming activities across multiple assets to deliver all data analysis outputs with quality and on time.
• Serves as the contact and advocate for the programming function in proposing, negotiating and managing delivery of programming expertise to enhance business processes.
• Leads initiatives to improve quality, efficiency or adherence to standards, including cross-functional initiatives across multiple departments
• Provides state-of-the-art programming knowledge / skills for process improvement initiatives or other major change initiatives.
• Effectively monitors quality within area of responsibility, including both internal and outsourced activities.
• Ability to build credibility and presence with customers at all levels of support
• Drives efforts to improve data visibility, quality and efficiency of flow from start-up through the reporting and archiving stages of clinical studies and system development including data re-use strategies (e.g., development of Quality Metrics/ Dashboards, Spotfire, data aggregation).
• Develops, implements and actively manages strategies to mitigate GSK's risk related to loss of revenue, intellectual property and corporate reputation.
Staff Mgmt, Development and Mentoring
• Manages multiple levels of programming staff. Includes staff located in multiple countries across multiple R&D sites
• Acts as ‘back-up’ for Programming Managers when necessary
• Drives capability development as it pertains to technology and associated processes.
• Liaises with and influences senior leaders across the organization to create operational efficiencies and differential development opportunities for programmers.
• Develops optimal resourcing / out-sourcing strategy for all assets and studies
• Facilitates optimum partnerships with CROs and other external partners.
• Partners with procurement and legal operations in vendor selection, contracting and performance oversight. Advocates compliance with such resourcing models.
• Effective relationship management of outsourced partners, demonstrating appropriate monitoring, risk assessment, risk mitigation and escalation of issues.
• Builds influential networks within the R&D Pipeline groups and / or other business areas. Uses these relationships to generate buy-in and support.
• Establishes a culture and strategizes programming activities not only meet the organizational objectives but also clearly meet external customer requirements necessary for GSK business success.
• Ensures compliance with GSK’s principles of data integrity in support of building sustainable public trust and maintaining GSK’s corporate reputation long-term.
• Effectively communicates, engages, and influences at the above-project/department level
Basic qualifications:• Bachelors / Masters/PhD Degree or equivalent with extensive (and in-depth) practical experience or proven experience at the expert level.
Preferred qualifications:• Demonstrated ability to influence management, stakeholders, and staff to adapt to positive change.
• Experience in line management of staff.
• Broad understanding of external landscape with respect to role and its related functions (e.g., Clinical Data Interchange Standards Consortium (CDISC), cancer Biomedical Informatics Grid (caBIG), outsourcing strategies).
• Experience in leading teams and business improvement efforts with positive results.
• Experience in applying creative thinking/business analysis skills in order to improve or solve business problems.
• Demonstrated effectiveness in building, managing and leveraging networks/client relationships internally
• A solid level of understanding of the pharmaceutical regulatory and publishing processes (e.g. 21 CFR Part 11)
• Demonstrated knowledge of and experience in the application of CDISC data and standards, primarily the creation and use of ADaM datasets
• Knowledge of basic computer skills (MS Word, Excel, PowerPoint, Outlook)
• Ability to manage conflicting demands and priorities and to negotiate successfully
• Project management or relevant experience
• Demonstrated ability to manage the outsourcing or externalization of statistical programming work in the clinical trials setting (e.g.working with CROs, academic institutions)
• Effective written and verbal communication skills
Why GSK?:At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
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