Site Name: USA - Pennsylvania - Upper Providence, Belgium-Wavre, Mississauga Milverton Drive, UK - Hertfordshire - Stevenage, UK – London – New Oxford Street, Warsaw
Posted Date: Nov 12 2024
GSK’s success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
The Clinical Operations Asset Lead represents all Clinical Operations functions at the asset level and at the Medicines Development Team and other asset team interactions and is accountable for developing the operational strategy and delivery plan to execute the scientific strategy for an asset and associated studies, working in partnership with clinical / biostats / clinical supplies and the functional subject matter experts to ensure informed asset decision-making from the operational, scientific and data perspectives.
Key Responsibilities
Your responsibilities will include the following:
* Contribution to the development of the Clinical Development Plan (CDP) and Integrated Evidence Plan (IEP), during Research, Development and Life Cycle Management phases of the asset lifecycle.
* Leads resourcing discussions and accountable for the final strategy (in vs outsourcing) for the asset and studies, in accordance with the resourcing strategy & principles.
* Lead escalation point from study and asset level to raise and assist with issues on behalf of the team, including serious quality incidents and serious breaches of GCP.
* Accountable for the operational planning, feasibility and delivery of their assigned asset(s) and associated Development Plan(s), on time and on budget, from beginning to end whilst optimizing time and cost efficiency, including resource utilization.
* Ensure asset level operational risk management plan is in-place and applies a smart-risk taking philosophy.
Basic Qualifications
* Bachelor’s degree or equivalent in Life Science, Scientific or equivalent.
* 10 years plus experience in managing clinical research projects or equivalent. Has an excellent understanding of project development, quality requirements and associated processes.
* Excellent knowledge and 5 years plus experience in clinical development and matrix management is required.
Preferred Qualifications
* Master’s Degree/Advanced Degree in Life Science, Scientific, or equivalent.
* Experience working independently with senior executives and the ability to quickly build personal credibility and assimilate business issues/need.
* Highly effective verbal, written, presentation communications skills.
* Demonstrated ability to build trust and strengthen collaborative relationships with matrixed team members across teams, sub-teams, and functions.
* Knowledge of established models for critical thinking, innovation, negotiation, and influencing skills.
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Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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