AbbVie is seeking a Medical Operations Lead in the UK. This is a newly created leadership role with a strong compensation and benefits package and opportunities to develop your career.
Location
Office based in Maidenhead (hybrid working model 3 days in office).
Overview
The 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 internal and external partnerships to drive and execute innovative ideas across all therapy areas.
* Acts 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 gaps.
* Oversees resource allocation, vendor relationships, and financial management for research and publications, while continually enhancing user experience and operational efficiency through feedback-driven improvements.
* Responsible for supervising SOP and TMF management, archiving, CRO vendor assessment, and tracking Pre-Approval Access programs.
Key Responsibilities
* Partner with affiliate Medical Teams to project manage study documents and execute clinical research projects.
* Collaborate cross-functionally to translate evidence gaps into Real World Evidence projects from setup to publication.
* Manage and develop a team, aligning activities with medical priorities and providing training and support.
* Allocate resources and oversee workload planning based on team needs.
* Supervise development, implementation, and follow-up of affiliate clinical studies and academic partnerships.
* Ensure quality control by defining, monitoring, and reporting on key quality indicators and driving continuous improvements.
* Provide operational input on protocol design, eCRF, and statistical analysis, and support feasibility and ethics submissions.
* Oversee data management, vendor relationships, compliance, study tracking, and deliverables reporting.
* Manage study budgets, contracts, drug shipments, and ensure on-time, on-budget delivery through negotiation and process development.
* Lead implementation and monitoring of early and compassionate access programs, ensuring compliance with regulations and timely protocol reviews.
Experience Required
* Life Sciences Degree or equivalent experience, with Project Management qualification desirable.
* Experience in a clinical operations function, experience working in the pharmaceutical industry.
* Active contributor to cross-functional teams and/or working in matrix organizations is an advantage.
* Understanding of ICH clinical guidelines.
* Experience in managing and leading teams.
Skills Required
Business Acumen:
* Ability to engage with business partners in a “business outcomes and challenges” conversation, not just a technical one.
* Anticipates and recommends technical solutions to business problems.
* Understanding of relevant legislation and regulations governing the pharmaceutical industry and identifying compliant solutions as required.
Strategic Thinking:
* Stimulates creativity and innovation in others. Open to new ideas.
Project Delivery:
* Communicates project progress by producing project reports to provide timely and accurate project status and decision support information to the Project Team.
Relationship Management:
* Establishes and maintains high-quality relationships with all levels across the company.
* Identified and acknowledged as the single point of contact for UK Medical Research Project needs.
* Responsible for maintaining relationships with third-party vendors and internal and external stakeholders.
* Experience in line management.
Additional Information
AbbVie 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 the (URL not displayed).
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more.
#J-18808-Ljbffr