This job within Global Clinical Delivery (GCD) combines end-to-end design, execution, and reporting of clinical trials with leadership in project teams and across matrix teams.
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.
- Bachelor’s degree in life sciences or neuroscience
- Extensive experience within the pharmaceutical industry or CRO environment in clinical operations
- Experience of leading study teams
- Experience in study management, global regulatory guidelines and ICH/GCP
- Experience in developing and writing study protocols, study procedures manuals, informed consent forms and clinical study reports.
- Experience working with investigators, external experts, Contract Research Organizations and vendors
- 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.
- Advanced degree in life science or related field (e.g., MS, PhD, PharmD) or equivalent experience
- 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.
- Demonstrated experience leading matrix environment to deliver projects, develop clinical plans, and manage change.