Head of Development Clinical Programming (Irwin)

GlaxoSmithKline PLC in Irwin, PA

  • Industry: Scientific Research - Health/Medicine/Pharmacology
  • Type: Full Time
  • $95,660.00 - 139,760.00
position filled
GlaxoSmithKline is one of the world's foremost pharmaceutical and healthcare companies, with statisticians and programmers working in Research and Development with a global footprint spanning the UK, US, Canada and India. The Biostatistics division includes a Clinical Programming department, covering all phases of clinical drug development and commercialization in a wide range of therapeutic areas. Programming's deliverables form the core of all regulatory submissions, health authority assessments, safety updates and publications (for peer review journals and scientific meetings).
In recognition of the developing sophistication and technical requirements of the role, Clinical Programming was formed as a standalone department distinct to Clinical Statistics. Programming asset teams are stepping up to achieve the goal of being the Biostatistics' leaders of delivery and execution, in a way that optimises, expedites and delivers to the highest quality. 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 and external 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.
The Clinical Programming organization at GSK has a strong focus on innovative ways of working and we are leading the way to implement these innovations and embracing an evolution for increased data science skills; this is already resulting in the introduction of new programming languages, technology and software. Some of these initiatives include the pathway for adoption of R and Python open source coding into day to day programming tasks, exploring machine learning to drive efficiencies for clinical reporting, developing desktop visualisation capabilities and we even have an annual challenge for Programmers who are rewarded for bringing new innovations into the department. But it's not just about the tech! We also encourage involvement in other initiatives too and we focus on personal development of staff, building project and leadership skills, inter-departmental liaison and collaboration skills and provide opportunities to get closer to the science and decision making.
The Head of Development Programming will provide senior global leadership, bringing together Programming teams across the large and diverse non-Oncology portfolio. This includes therapeutic areas such as Immunology, Inflammation, Fibrosis, Respiratory and an additional varied portfolio spanning multiple specialist disease areas. You will need to be strategic in the use of internal and external resource and provide leadership and oversight to ensure that Programming asset teams execute and deliver in a way that optimizes, expedites and delivers high quality in support of regulatory submissions, health authority assessments, safety updates and publications (for peer review journals and scientific meetings). Exceptional leadership skills are critical to manage the large, globally distributed Development (non-Oncology) Programming group and you will be an influential, visionary, strategic and innovative leader with a broad knowledge of the complexities and challenges across multiple and diverse disease areas. Additionally, success will be accomplished by attracting into the organization industry-leading programming expertise and driving advocacy for effective use of modern-day tools, technologies, processes and standards.
Key Responsibilities
  • Member of the Programming Leadership Team, with accountability for co-developing, representing and driving forward overall Department vision, goals and strategy.
  • Provide senior leadership, vision, management and direction to the global Development Programming group, and develop a strong leadership team who have credibility and influence within Programing and across the matrix.
  • Drive operational excellence agenda for Development Programming; lead clinical data strategy, safeguard clinical data integrity and ensure efficient, high quality, timely execution of clinical trial data and submission deliverables across the non-Oncology portfolio
  • Develop and maintain nimble organizational models to optimize the blend of internal/external resource deployed across all Development Programming deliverables. Adapt to pipeline and priority changes and effectively integrate new projects and staff through alliances and acquisitions.
  • Lead point of contact with high credibility and authoritative voice for senior Development Stakeholders when it comes to all Programming aspects of Development, ViiV and Global Health R&D (technical, delivery, execution). Build strategic partnerships with key functional groups across the matrix (Clinical, Operations, Commercial, Regulatory, Safety, Epi, Business Development). Influence to ensure strategies are aligned, optimal and practical.
  • Ensure that programming approaches adopted are at the cutting edge of industry; Build internal capability and external relationships to ensure such an outcome and foster a culture for technical innovation in line with the Programming vision. Furthermore, to 'push the envelope' to continually seek innovative ways to expedite delivery of medicines, such as FDA's Real Time Reviews.
  • Ensure their groups adherence to all current GSK policies/procedures and regulatory requirements for research, development, submission, reimbursement and commercialization. In addition, ensure that all aspects of their groups conduct are aligned with GSK's integrity principles.
  • Develop key talent and champion empowerment of individuals/teams across the organization
  • Augment GSKs network by bringing to Programming new and valuable relationships and apply best practices. Ensure effective contributions in relevant external initiatives and establish/leverage networks amongst other Pharma Programming Heads
  • Why You?
    Basic Qualifications:
  • Bachelors / Masters / PhD Degree or equivalent
  • Experience within Programming, Biostatistics (or similar quantitative group) with expertise in SAS or other programming languages used for the analysis, reporting and visualisation of clinical trial data.
  • Experience leading teams
  • Knowledge of medicine development strategies and the drug development process.
  • Preferred Qualifications:
  • Well regarded and respected leader; proven ability to lead a large global team in a similar technical delivery discipline. Highly credible within the broader programming community and with senior stakeholders across GSK.
  • Track record of being able to influence internal and external stakeholders on challenging medicine development, reimbursement and product-stewardship issues
  • A track record of building, leading, managing successful teams, navigating ambiguity and delivering innovative solutions to complex problems.
  • Significant experience across breadth of Biostatistics with strong knowledge of the clinical programming (primary), statistical, regulatory, scientific and technical landscapes. Deep understanding of programming function technical processes and challenges (e.g. CDISC)
  • Experience in leading significant business improvement efforts or change projects with a track record of achievement; efforts that required influence of senior stakeholders, management and staff to adapt to positive change
  • Strong vision of a future programming discipline and drive to achieve this vision.
  • Business acumen - understands implications of decisions from a broad business perspective and uses this knowledge to influence decision-making at the highest levels of R&D.
  • A track record of effective leadership in a variety of roles including interfacing with partner groups to shape business and drive business improvement/create value.
  • Broad appreciation of the drug discovery/development process and a proven ability to bridge disciplines to influence and shape decision-making and culture.
  • A strong sense of initiative, urgency, drive, pragmatism and judgement - overall an ability to make things happen.
  • Will likely have an external presence and a strong network across the industry. Expected to build/extend this to be aware of industry trends in programming and biostatistics functions
  • A champion of effective, novel approached and the vision to see how these can positively impact our business
  • Proven ability to deliver to demanding deadlines whilst maintaining the highest quality.
  • Effective influencer of many different personality types across all levels of seniority.
  • Proven ability to develop skills and capabilities, with demonstrated leadership in the application of innovative approaches with directorate-level impact. Works with peers to move the Programming community to a leadership position in the industry.
  • Comfortable operating with little direction and effectively navigating ambiguity
  • 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.
    *LI-GSK
    GSKSPTalent
    If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1- (US Toll Free) or +1 (outside US)...... click apply for full job details
    Associated topics: .net, algorithm, application, backend, c#, develop, java, matlab, php, software development engineer

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