NHS Human Services, Inc.

Reference #: 399353 Site Name: UK - Hertfordshire - Stevenage, Upper Providence, USA - Pennsylvania - Upper Providence Posted Date: Jun 21 2024

The Scientific Operations (SO) Group within the PMed group provide operational management of Biomarker and Companion Diagnostic activities in Clinical Trial Assay Development; Clinical Trial Setup, Execution and Closeout; external Vendor Management; and Collaborations. The Scientific Operations Associate Director is responsible for working with clinical biomarker/virology leads to deliver the biomarker/virology strategies through robust budget plans and optimal outsourcing engagements.  This includes leading human biological sample management (HBSM) activities for biomarker samples within clinical trials for one or more GSK Asset Programs and managing a small team as required.  The role holder will work closely with a wide variety of functions within GSK and external, to align, plan and deliver the required operational activities.  The role holder is accountable to ensure all required details of the biomarker strategy are adequately described in the clinical protocol and informed consent. We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

In this role you will Drive operational delivery of biomarker strategies developed by Clinical Biomarker and Virology leads within clinical trials. Accountable for sample management strategy and is the Business Owner for Specialty Testing Labs managing key activities with laboratory partners including technical qualification, sample analysis plans, validations and analytical reports. Ensure all activities are completed within time, quality and budget requirements and aligned with agreed sample management strategy. Provide expert input into Clinical Trial documentation including Protocols, Informed Consent Forms, data transfer agreements, lab manuals and central lab specifications to ensure scientific operational aspects are fit for the intended purpose Ensure alignment of biomarker outputs with Data Management, Biostats and modelling/simulation requirements. Provide expert input into data transfer agreements. Work with Clinical Operations to draft Site Communications and Training Materials; Train CRO and Internal Teams on sample collection/processing activities as required. Accountable for identification, documentation and management of risks within assigned projects Why you? Basic Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: * Bachelor's degree in a science or health related discipline * Experience in: clinical trial specimen management including collection/process of diverse sample types, laboratory management, LIMS and project management * Knowledge and understanding of the clinical development process, GxP and global regulatory requirements * Excellent communication skills and good interpersonal and matrix working skills * Self-motivated with ability to work independently as well as a highly motivated team player with a proactive attitude and ability to interact effectively within a multi-disciplinary team including internal and external technical and business experts Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do not have them, please still apply: * Master's degree or equivalent experience * Management experience * Demonstrated knowledge of Chinese regulatory requirements and expectations for sampl analysis including sample exportation * Experience with validation and implementation of biomarkers Closing Date for Applications - 5/7/24 (COB) Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

#LI-GSK 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).

Our 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.

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