Job Purpose and Key Responsibilities:
This job is within Global Clinical Science and Delivery (GCSD) combines end-to-enddesign, execution, and reporting of clinical trials with leadership in project teams and across matrix teams. Studies will mainly focus on supporting those in the early phase of clinical research (Phase 1 and 2).
Key attributes include scientific credibility, demonstrated ability to input to and influence studies/projects through scientific and operational expertise, and demonstrated excellence in stakeholder management. This job requires strategic thinking, solution-finding, and agility as evidenced by flexibility, adaptability to change, curiosity, and ability to lead and drive change.
Essential behaviours valued include: Continuous improvement and learning, effectiveness at building networks of partners and stakeholders, and ability to lead and inspire others. A track record of applying experience and judgement towards project decision-making, effective peer review, and shared learning is essential.
This position may contribute to individual studies in addition to project level activities, as appropriate, including responsibility and/or accountability for the set-up, coordination, execution and delivery of one or more studies, programs, or groups of programs from one or more therapy areas, specifically:
- the delivery and quality of all clinical studies from protocol concept to final study report and for the validity of all data originating from studies supporting their portfolio.
- reviewing and/or enhancing the technical and scientific robustness of clinical plans and studies developed by the key customers for their designated area, while inputting and influencing.
- compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies.
- Making decisions which balance risk/benefit with clear understanding of impact on project; takes action to mitigate risk where appropriate.
- Requires active partnership building for their portfolios and collaboration with therapy aligned staff in other functions. Interact effectively across boundaries with other global functions using influencing and relationship-building skills.
The position may include:
- Leadership of a study team with single point accountability for delivery of the study, or working in support of colleagues in GCSD who have that accountability
- Working closely with senior functional leaders to ensure that budget and human resources within the group are assigned effectively to meet portfolio demands. Work with matrix partners to develop and manage study level budget within project budget allocation. Look for ways to use resource most effectively to manage workload within IPE/EPE budget and headcount allocation.
- Lead and drive significant cross-therapeutic/functional business change initiatives according to company and/or group strategy and business needs. Be accountable for implementing new business processes and strategies; may also proactively identify issues, and propose strategies to manage implications and risks on clinical study/studies timelines, budgets and goals.
- Have an established track record of generating alternative solutions and perspectives at project and line level. Encourage others within matrix and line teams to seek alternative perspectives and develop solutions.
- Lead, build, and motivate a global team of clinical development scientists/managers/directors
- Accountability for the management, performance and motivation of all direct reports, as applicable.
- Be accountable for managing the workload, resource requirements, and commitment to timelines and budget for their portfolios based on current and likely future workloads
- Have primary responsibility and be a focal point of contact for interactions with specified Medicines leaders or EDLs (e.g. MDLs), Research Units, and other key stakeholder groups including biostatistics, clinical pharmacology modelling and simulation (CPMS), project management etc.
- Broad understanding of the pharmaceutical industry and the clinical development process
- In depth knowledge of either study management or data management and knowledge of essential regulatory guidelines worldwide and GSK company policies.
- Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment
- Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary
- Excellent influencing and negotiation skills.
- Proven expertise in the proactive identification of issues which may impact clinical programmes coupled with the ability to contribute to solutions affecting cross-functional matrix teams.
- Excellent leadership skills.
- Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience
- Demonstrated experience leading in both matrix and line environment to deliver projects, develop clinical plans, and manage change
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