Medical Operations Lead

Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.Job DescriptionOffice based in Maidenhead (hybrid working model 3 days in office). Reporting to the Head of Medical Operations. Newly created leadership role at AbbVie UK: excellent compensation and benefits package, with great opportunities to develop your career.Job OverviewThe Medical Operations Lead will provide leadership and oversight, to ensure medical projects are delivered on time and executed compliantly.Provides strategic leadership in study operations, fostering strong internal and external partnerships to drive and execute innovative ideas across all therapy areasActs as an Affiliate Subject Matter Expert in clinical research and study management, collaborating with key stakeholders to deliver Real World Evidence projects that address research gapsOversees resource allocation, vendor relationships, and financial management for research and publications, while continually enhancing user experience and operational efficiency through feedback‑driven improvementsResponsible for supervising SOP and TMF management, archiving, CRO vendor assessment, and tracking Pre‑Approval Access programs.Key ResponsibilitiesPartner with affiliate Medical Teams to project manage study documents and execute clinical research projectsCollaborate cross‑functionally to translate evidence gaps into Real World Evidence projects from setup to publicationManage and develop a team, aligning activities with medical priorities and providing training and supportAllocate resources and oversee workload planning based on team needsSupervise development, implementation, and follow‑up of affiliate clinical studies and academic partnershipsEnsure quality control by defining, monitoring, and reporting on key quality indicators and driving continuous improvementsProvide operational input on protocol design, eCRF, and statistical analysis, and support feasibility and ethics submissionsOversee data management, vendor relationships, compliance, study tracking, and deliverables reportingManage study budgets, contracts, drug shipments, and ensure on‑time, on‑budget delivery through negotiation and process developmentLead implementation and monitoring of early and compassionate access programs, ensuring compliance with regulations and timely protocol reviewsQualificationsExperience RequiredLife Sciences Degree or equivalent experience, with Project Management qualification desirableExperience in a clinical operations function, experience working in the pharmaceutical industryAs an active contributor to cross‑functional teams and/or working in matrix organizations will be an advantageUnderstanding of ICH clinical guidelinesExperience in managing and leading teamsSkills RequiredBusiness AcumenAbility to engage with business partners in a “business outcomes and challenges” conversation and not just a technical conversation.Anticipates and recommends technical solutions to business problems.The individual must have an understanding of relevant legislation and regulations governing pharmaceutical industry and identify solutions that are compliant with the legislations, as and when required.Strategic ThinkingStimulates creativity and innovation in others. Open to new ideasProject DeliveryCommunicate project progress by producing project reports to provide timely and accurate project status and decision support information to Project Team.Relationship ManagementEstablish and maintain high‑quality relationships with all levels across the company.Identified and acknowledged as the single point of contact for UK Medical Research Project needsResponsible for maintaining relationships with our third‑party vendors and internal and external stakeholders.Experience in line managementAdditional InformationAbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html. US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html. #J-18808-Ljbffr