A high profile, global leadership opportunity within our Quantitative Sciences business. The role is reporting to the Head of Clinical Programming, and we are searching for an individual with both strength and depth in biostatistics to lead a Therapeutic Area within the global clinical programming function.
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- Defines and drives the programming strategy across a therapy area or function.
- Oversees programming activities across multiple assets, a therapeutic area or a function 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 services to enhance business processes.
- Leads standard and process development to garner efficiencies within programming and cross- functionally.
- Advocates strict adherence to standards and processes.
- Provides state-of-the-art programming knowledge / skills for process improvement initiatives or other major non-clinical change initiatives.
Scope of Responsibility ...
Staff Mgmt/Development/Mentoring;
1) 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
2) Drives capability development as it pertains to technology and associated processes.
3) Liaises with and influences senior leaders across the organization to create operational efficiencies and differential development opportunities for programmers.
R&D Pipeline;
1) Develops optimal resourcing / out-sourcing strategy for all assets and studies
2) Facilitates optimum partnerships with CROs and other external partners.
Vendor Management;
1) Partners with procurement and legal operations in vendor selection, contracting and performance oversight.
2) Advocates compliance with such resourcing models.
3) Develops relationships and interacts with vendors to provide feedback, manage issues and mitigate risks to output quality.
Impact and Risk ...
- 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.
Problem Solving ...
- Evaluates and implements strategic resourcing strategies and options that will support FDA/R&D initiatives.
- Provides high level expert input into organizational changes (e.g., structural changes)
- Takes decisions and implements the strategy for critical computing changes (e.g., new database/ reporting systems). Involvement in defining Data Quality and Statistics & Programming Community strategies and partnerships (e.g., computing / license agreements).
- Assesses and implements new developmental and innovative opportunities for programming function.
You will also ...
- Build influential networks within the R&D Pipeline groups and / or other business areas. Uses these relationships to generate buy-in and support. - Establish 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.
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