Director, Medical Review Scientist - CTMRT At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D Position Summary GSK is expanding the Oncology Clinical Development organization and we are seeking experienced professionals to join our exciting journey. GSK Oncology has a commitment to the discovery and development of new oncology therapies with the life-changing potential of helping patients with cancer. Oncology Clinical Development is a specialized Clinical Trial Medical Review Team (CTMRT) that is wholly integrated within the global Oncology Clinical Development function and composed of Medical Review (MR) Scientists and MR Physicians. CTMRT staff, composed of Clinical Scientists and Physicians, integrates seamlessly with the core study team and be highly valued Medical Review subject matter experts (SMEs) with a focus on excellence in content and delivery of instream medical review with the goal of delivering a complete, robust, and medically accurate data package. The CTMRT works with fellow Oncology Clinical Development staff from a centralized work location that has close ties with other functions located at the local site. As a Director, Medical Review Scientist - CTMRT you are responsible for performing medical review activities across multiple oncology studies with a wide range of therapeutic modalities and tumor types, as well as mentoring Associate Director MR Scientists. Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: - Responsible for the medical consistency and robustness of clinical data that cannot be processed by computerized means: Iterative, in-stream, standardized data review that employs medical judgment, with intent to ensure data accurately and completely reflect the clinical course of participant(s) in the study - Review and contribute to study-related documents such as protocols, medical monitoring plans, statistical analysis plans, data management plan, eCRFs, eCRF completion guidelines, database edit checks, risk-based monitoring plans, etc.; may contribute to site training activities and supporting the study team and CRO personnel regarding all MR-related aspects of the trial - During study set-up phase, in collaboration with the Data Management and Clinical Development team, the MR Scientist develops a Medical Review Plan (MRP) for the study, which details the scope of the medical review and appropriate timelines s/he performs on the study data. This review requires a holistic approach within and across study participants, and a deep understanding of the study protocol, patient population, and medical knowledge. The medical review will encompass participant eligibility, protocol adherence, medical consistency, safety checks, as well as efficacy checks when appropriate. The MRP is a “living document” and will be updated and adapted as the study progresses, in collaboration with the Data Management and Clinical Development teams - Assist in setting up medical review tools that support medical review throughout the study, such as reviewing the specifications, identifying critical variables, and performing user acceptance testing (UAT) During the data collection phase, the MR Scientist executes medical review for which s/he is responsible as defined in the MRP during the set-up phase Collaborate with the Centralized Monitoring team to identify key study risks based on the iterative medical review Support medical coders to ensure consistency and accuracy of adverse events, medical history, and concomitant medication coding Review statistical program outputs (i.e., tables, figures, and listings – or TFLs) during study to identify inconsistencies in data capture and areas that need to be addressed by the CTMRT Accountable to the Clinical Study Team for: review of medical-related protocol deviations, raising and responding to medical queries in the database, analysis of trends for data inconsistencies and flagging areas that require additional site training, etc. May be responsible for developing site training materials to address those issues Participate and contribute to weekly core study team meetings and update the teams on the status of medical review, trend analysis, etc Identifies program, trial or data risks, creates, and implements mitigation strategies in collaboration with the Clinical Study Team as appropriate Support the Data Management team in ensuring the eCRFs and eCRF completion guidelines accurately reflect the patient population under study and the scope of the protocol Require a close collaboration with the study’s Clinical Development team (i.e., Study Physician, Clinical Scientist) as well as Patient Safety to discuss/review complex medical questions and concepts Basic Qualifications We are seeking professionals with the following required skills and qualifications to help us achieve our goals: - Bachelors in Life Science degree with 8+ years of industry and 3+ years of experience in Oncology or, in lieu, relevant clinical experience and demonstrated capabilities and experiences - Experience with data review/interpretation, study design and the clinical development process - Experience using electronic data capture (EDC) systems, query management, and Medical Review tools - Knowledge of regulatory requirements to support registration, including knowledge and adherence to GCP principles - Expert communicator (i.e., excellent command of spoken and written English) with outstanding presentation skills are essential - Must be able to work productively in a fast-paced collaborative environment with a positive attitude Preferred Qualifications If you have the following characteristics, it would be a plus: - Advanced degree (e.g. Masters, PhD, PharmD) or 10+ year of experience or, in lieu, relevant clinical experience and demonstrated capabilities and experiences - Advanced understanding of clinical development and/or marketed support to recommend, influence, and implement improvements to processes. Work Location: This role is based in Warsaw, Poland or Mississauga, Canada and offers a hybrid working model. If you’re passionate about advancing clinical development and making a difference in patients’ lives, we encourage you to apply today! Please provide your resume and a cover letter. 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. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. 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Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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. Find out more on our career site.
