Site Name: Canada - Ontario - Mississauga, UK - Hertfordshire - Stevenage, UK - London - Brentford, USA - Massachusetts - Waltham, Warsaw, USA - Pennsylvania - Upper Providence Posted Date: Aug 19 2021 GSK continues to expand its oncology organization, and we are looking for experienced professionals to help us rebuild and grow our internal expertise! We have an exciting (and expanding) portfolio and are looking for Clinical Operations Leaders who have experience leading global studies. It's a wonderful time to join our team because have multiple open positions in the areas of immuno-oncology, cell/gene therapy, epigenetics and synthetic lethality. Apply to learn more! Remote working outside of listed locations may be considered for the qualified applicant by exception and given willingness to agree to ways of working which meet both the needs of the individual and the business. This position within Global Clinical and Study Delivery (GCSD) and is accountable for planning and leading the delivery of oncology studies to time, quality, budget, company standards and scientific requirements as outlined in the clinical study proposal. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Accountable for the study delivery strategy (e.g. country selection, diversity, patient engagement strategy, recruitment plan, etc) Drive assessment, selection, engagement, and management of appropriate vendors. Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies. Make decisions which balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate. Work with matrix partners, asset lead and/or manager to develop and manage study level budget within project budget allocation. Actively partner to build relationships and collaborate with oncology aligned staff in other global functions. Experience successfully leading global cross-functional teams in Cell and Gene Therapy/CAR-T trials Understanding and ability to manage the operational challenges unique to Cell Therapy/CAR-T trials especially those related to vendor management, Supply Chain and CMC. Solid background in managing Phase 1, including First Time in Human Trials Why you? Basic Qualifications We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in life sciences or related discipline; 6 years of clinical development experience in the pharmaceutical industry or CRO environment Global clinical operations leadership experience Experience in study management, global regulatory guidelines and ICH/GCP Experience working with investigators, external experts, Contract Research Organizations and vendors Preferred Qualifications: If you have the following characteristics, it would be a plus: Experience leading the delivery of oncology clinical trials is preferred. Clinical development experience across all phases of development (I-IV). 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