Gilead
Job title:
Director – Actual-World Proof (Observational Analysis Operations)
Firm
Gilead
Job description
For Present Gilead Staff and Contractors:Please log onto your to use for this job.At Gilead, we’re making a more healthy world for all folks. For greater than 35 years, we’ve tackled illnesses reminiscent of HIV, viral hepatitis, COVID-19 and most cancers – working relentlessly to develop therapies that assist enhance lives and to make sure entry to those therapies throughout the globe. We proceed to struggle in opposition to the world’s largest well being challenges, and our mission requires collaboration, willpower and a relentless drive to make a distinction.Each member of Gilead’s workforce performs a important function within the discovery and growth of life-changing scientific improvements. Our staff are our best asset as we work to realize our daring ambitions, and we’re in search of the subsequent wave of passionate and bold folks able to make a direct affect. Be part of Gilead and assist create potential, collectively.Job DescriptionDirector – Actual-World Proof (Observational Analysis Operations)Gilead Sciences, Inc. is a research-based biopharmaceutical firm based in 1987, that has pursued and achieved breakthroughs in medication for greater than three many years, with the purpose of making a more healthy world for all folks.Collectively we ship life-saving therapies to sufferers in want. With the dedication and drive you carry to the office day-after-day, you’ll be a part of a workforce that’s altering the world and serving to hundreds of thousands of individuals stay more healthy, extra fulfilling lives. Our worldwide employees is a detailed group the place you possibly can see the tangible outcomes of your contributions, the place each particular person issues, and everybody has an opportunity to reinforce their abilities via ongoing growth.Leveraging robust group abilities and scientific analysis operations background, the RWE Observational Analysis Operations Director performs an integral half in audit readiness via operational administration and oversight of observational analysis research and observational analyses inside the Gilead Medical Knowledge Science Actual-World Proof (CDS-RWE) operate.This function reviews to the top of CDS-RWE Era. The Director will lead efforts to make sure implementation and well timed monitoring of observational examine milestones and deliverables. This function will probably be chargeable for definition and implementation of metrics that monitor end-to-end observational analysis associated actions and guarantee audit readiness.This function is accountable to observe developments, determine areas of enchancment and collaborate with observational examine stakeholders to repeatedly enhance processes for observational examine conduct, high quality, and compliance inside the CDS-RWE operate.It is a complicated function and requires collaboration with observational analysis stakeholders inside RWE and with different features like Medical Operations, Medical Affairs, GHEOR and Biomarker Sciences.. The profitable candidate has expertise in drug-development course of, scientific examine lifecycle, regulatory compliance, and the makes use of of actual world proof in scientific growth and security endeavours. They’ve demonstrated consideration to element, program and challenge administration experience, and the power to thrive in a posh, quick paced, matrixed group. Moreover, the perfect candidate may have the confirmed capacity to successfully talk to senior leaders of the group.Core DutiesBecause the lead particular person chargeable for operational monitoring and audit readiness for observational research inside the RWE operate:Accountable for making certain that each one research led by the RWE operate are audit prepared and in compliance with native and nationwide rules and with Gilead procedural docEnsures examine documentation are in compliance with all relevant regulatory necessities, business requirements, and Gilead inside insurance policies all through the conduct of RWE research; ensures study-level audit readiness for CDS-RWE; assists with responses to course of deviations and employees coachingImplement metrics to trace high quality and audit readiness of CDS-RWE deliverablesDevelops, implements and screens processes for end-to-end monitoring, e.g., from examine initiation, examine contracting, examine conduct, examine closeout. Helps budgeting, invoicing, and forecasting of examine prices; Builds a workforce to assist these efforts independently with virtually no direct supervision.Construct and lead functionality to supervise observational examine documentation together with regulatory system administration, trial grasp file, scientific trial administration system (as wanted) with virtually no direct supervision.Oversee the administration of exterior distributors and analysis companions concerned in real-world proof research, together with contract negotiation, efficiency monitoring, and price range administration. Independently organizes the operations, planning and contracting with exterior companions.Together with the CDS-RWE Therapeutic Space examine leads, oversees the event of examine timelines and tracks milestones to make sure deliverables are met; Observe CDS-RWE initiatives and achievements over the yr; Create metrices for monitoring the standing of NIS to assist examine replace displays management.Work intently with Head of CDS-RWE Era and examine results in observe proof technology actions within the applicable system(s); Oversees examine operational assist together with monitoring and reporting; as new instruments are developed to assist observational examine conduct, leads implementation effortsContribute to the strategic planning and execution of proof technology initiatives to assist product growth, regulatory submissions, and market entry actionsImplements challenge to construct functionality inside CDS-RWE and coordinates course of enchancment initiatives with stakeholders inside RWE, CDS and throughout Improvement organizationsUnderstands operational necessities and interprets these into actions for high quality and course of enchancment by interacting with staff and different groupsLead growth of communications technique and preparation/content material together with CDS-RWE course of trainings and challenge/initiative displaysLead some key RWE Era initiatives with cross-functional companionsCapabilities and NecessitiesReveals knowledgeable data associated to the conduct of operational points of observational analysis, together with observational research and evaluation. Understands key enterprise processes and enterprise areas. Acts as useful resource and offers route to others. Has in-depth data of the multidisciplinary features concerned in drug discovery and growth and might proactively combine a number of views into analysis and/or growth assignments.Robust organizational administration abilities, together with consideration to element and cross-functional communicationImplementation of program and/or portfolio administration, monitoring and dashboardsRobust management and communication abilities throughout features; consolation in enterprise and technical discussions. Capable of affect with out direct authorityConfirmed management expertise, with a observe document of successfully managing groups and driving ends in a matrixed group.Experience in administration of techniques for examine monitoring and reportingExtremely resourceful and strategic thinker with robust emotional intelligence and operational rigorConfirmed observe document cross-functional collaboration inside a matrix group and efficiently managing complicated, time-sensitive, transformational initiativesConfirmed observe document of concurrently managing a number of initiativesEarlier administrative and organizational growth expertise in actual world proof or scientific analysisExperience with processes and techniques throughout RWE analysis disciplines, examine, knowledge and evaluation lifecyclesThe perfect candidate may have demonstrated management in strategic planning and executionExpertise driving massive initiatives from framing the issue, conducting analysis / evaluation to constructing the enterprise and operational plans via to driving execution to success is requiredSelf-starter who thrives in a fast-paced, collaborative, and progressive high-growth surroundingsRestricted journeyTrainingBS, MS/MBA, PhD/PharmD or equal with important expertise in RWE/RWD/EpidemiologySuperior diploma in a scientific area related to RWE (e.g., epidemiology, public well being, knowledge science, scientific analysis) most well-likedThe Gilead DistinctionEverybody at Gilead is motivated by our overarching mission to find and ship progressive therapies that enhance affected person care in areas of unmet medical wants. However it’s simply what we do that provides us an edge, it’s how we do it. We anticipate everybody at Gilead to guide by instance, guided by our core values:Integrity (at all times doing the precise factor)Teamwork (collaborating in good religion)Excellence (working at a excessive degree of dedication and functionality)Accountability (taking private duty)Inclusion (encouraging range)Equal Employment Alternative (EEO)It’s the coverage of Gilead Sciences, Inc. and its subsidiaries and associates (collectively “Gilead” or the “Firm”) to recruit choose and make use of probably the most certified individuals obtainable for positions all through the Firm. Besides if in any other case supplied by relevant legislation, all employment actions referring to points reminiscent of compensation, advantages, transfers, layoffs, returns from layoffs, company-sponsored coaching, schooling help, social and leisure packages are administered on a non-discriminatory foundation (i.e. with out regard to protected traits or prohibited grounds, which can embrace a person’s gender, race, colour, nationwide origin, ancestry, faith, creed, bodily or psychological incapacity, marital standing, sexual orientation, medical situation, veteran standing, and age, until such safety is prohibited by federal, state, municipal, provincial, native or different relevant legal guidelines). Gilead additionally prohibits discrimination based mostly on some other traits protected by relevant legal guidelines.For Present Gilead Staff and Contractors:Please log onto your to use for this job.
Anticipated wage
Location
Uxbridge, Better London
Job date
Sat, 06 Apr 2024 22:44:39 GMT
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