Senior Director, RWE Virology Safety Epidemiology Leadpage is loaded Senior Director, RWE Virology Safety EpidemiologyLead Apply locations United Kingdom - Uxbridge posted on Posted 7Days Ago job requisition id R0045122 At Gilead, we’re creating ahealthier world for all people. For more than 35 years, we’vetackled diseases such as HIV, viral hepatitis, COVID-19 and cancer– working relentlessly to develop therapies that help improve livesand to ensure access to these therapies across the globe. Wecontinue to fight against the world’s biggest health challenges,and our mission requires collaboration, determination and arelentless drive to make a difference. Every member of Gilead’steam plays a critical role in the discovery and development oflife-changing scientific innovations. Our employees are ourgreatest asset as we work to achieve our bold ambitions, and we’relooking for the next wave of passionate and ambitious people readyto make a direct impact. We believe every employee deserves a greatleader. People Leaders are the cornerstone to the employeeexperience at Gilead and Kite. As a people leader now or in thefuture, you are the key driver in evolving our culture and creatingan environment where every employee feels included, developed andempowered to fulfil their aspirations. Join Gilead and help createpossible, together. Job Description Position Description TheReal-World Evidence (RWE) function at Gilead is part of theClinical Data Sciences (CDS) group within the Developmentorganization and aims to unlock the power of Real-World Data (RWD)to help transform innovations to life-changing medicines forpatients. The Senior Director, RWE Virology Safety EpidemiologyLead reports to the Executive Director, RWE Therapeutic AreaHead-Virology and has primary accountability for the execution ofpost authorization and other non-experimental studies, bothmandatory and voluntary, in support of Virology product safety. Theincumbent will serve as the key subject matter expert for Virologypost marketing commitments (PMCs) and other pharmacoepidemiologyactivities in support of safety, and serve as a strategic partnerto the RWE Virology Product Area Leads and cross-functionalstakeholders to ensure excellence in the execution of all safetyepidemiology activities at the global level. The SD, RWE VirologySafety Epidemiology Lead will oversee a team of observationalresearch scientists within a matrix organization and advocate forthe appropriate level of resources to ensure the timeliness,quality, and utility of RWE Virology activities in support ofsafety required by internal and external stakeholders (e.g.,regulators). Success in this role requires excellence in design andconduct of epidemiologic studies, expertise in the use of data fromboth primary as well as secondary sources (e.g., fromadministrative claims, medical records, etc), expertise in the useand application of appropriate and state-of-the-art analyticalmethods at different stages of the product development andcommercialization lifecycle, and the ability to lead and managecross-functional efforts and resources. Duties &Responsibilities - Serve as the primary point of accountability forthe timely development, execution, and communication of specifiedpost-authorization/non-experimental studies for the safety ofindividual products and their pipeline/lifecycle indications inVirology. - Provide functional perspective and subject-matterexpertise on RWE methods and requirements at both theglobal/regional level and the TA level, including review of PMCstudy protocols and analysis plans developed internally andexternally. - Ensure collaboration and coordination of SafetyEpidemiology activities with RWE Virology Product Area teams - Leada team of observational research scientists within a matrixorganization to deliver, within time, budget, and qualitystandards, safety-related studies including, but not limited to:patient registries, signal evaluation studies using secondary data,drug utilization studies, comparative safety studies, andpost-approval safety studies. - Communicate effectively about theutility of RWE and drive use of study results to support internaland external decisions. - Ensure expert communication ofobservational research results, including development of studyreports and pertinent sections of regulatory documents,publications, white papers, press releases, etc. - Represent theRWE function in internal cross-functional initiatives and externalorganizations, such as industry associations, professionalsocieties, or regulatory working groups. - Foster closecollaborations with quantitative functions within CDS (e.g.,Biostatistics, Clinical Pharmacology, AI/ML Research Center), aswell as partners in Clinical Development, Global Patient Safety,Regulatory Affairs, Clinical Operations, Medical Affairs and GlobalValue and Access, to anticipate and meet the evidence needs ofregulators, payers, providers, and patients. - Actively identifythe need for the development of processes or gaps in trainingdocuments aimed at increasing the efficiency, quality, and impactof functional activities. Requirements - Doctoral degree (e.g. PhD,MD, ScD, PharmD) and/or Master’s degree (e.g. MSc) in Epidemiologyor related discipline, such as Outcomes Research, Medicine,Biostatistics from an accredited institution, - Relevantpost-graduation experience within the biopharmaceutical industry. -A strong track record of scientific publications demonstratingexpertise in observational study design, analysis, andinterpretation and direct experience with different applications ofRWE, especially in support of PAS. - Preference for understandingof the Virology therapeutic area, including disease knowledge,current treatment practice and guidelines, pertinent clinical trialendpoints and safety outcomes. - Strong preference for expertise instate-of-the-art methods, including AI/ML approaches, forleveraging RWD to assess safety and other questions - Solid workingknowledge of regulatory guidelines pertaining to RWD and RWEstudies, especially post-authorization studies. - Experienceleading, coaching, and managing people in a global, matrixedsetting. - Demonstrated ability to function with a high level ofautonomy and develop productive cross-functional collaborations. -Ability to manage priorities, resources, and performance targets,in a changing environment. - Ability to communicate proactivelywith others across functions to ensure shared purpose and clearaccountability for future decisions. - Well-developedcross-cultural sensitivity. Equal Employment Opportunity (EEO) Itis the policy of Gilead Sciences, Inc. and its subsidiaries andaffiliates (collectively "Gilead" or the "Company") to recruitselect and employ the most qualified persons available forpositions throughout the Company. Except if otherwise provided byapplicable law, all employment actions relating to issues such ascompensation, benefits, transfers, layoffs, returns from layoffs,company-sponsored training, education assistance, social andrecreational programs are administered on a non-discriminatorybasis (i.e. without regard to protected characteristics orprohibited grounds, which may include an individual’s gender, race,color, national origin, ancestry, religion, creed, physical ormental disability, marital status, sexual orientation, medicalcondition, veteran status, and age, unless such protection isprohibited by federal, state, municipal, provincial, local or otherapplicable laws). Gilead also prohibits discrimination based on anyother characteristics protected by applicable laws. For CurrentGilead Employees and Contractors: Please apply via the InternalCareer Opportunities portal in Workday. Similar Jobs (1) MedicalDirector, Clinical Development – Hematology/Oncology locationsUnited Kingdom - Uxbridge time type Full time posted on Posted 12Days Ago #J-18808-Ljbffr
