Medical Operations Lead - NEW in Maidenhead

Overview

The Medical Operations Lead role at AbbVie is a newly created leadership position based in the UK.

Job location: Maidenhead (hybrid: 3 days in office).

Job Description

Office based in Maidenhead (hybrid working model 3 days in office)

Reporting to the Head of Medical Operations

Newly created leadership role at AbbVie UK with excellent compensation and benefits package, and strong opportunities to develop your career

Key Responsibilities

• Provide leadership and oversight to ensure medical projects are delivered on time and executed compliantly
• Provide strategic leadership in study operations, fostering internal and external partnerships to drive and execute innovative ideas across all therapy areas
• Act 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
• Oversee resource allocation, vendor relationships, and financial management for research and publications, while improving user experience and operational efficiency through feedback-driven improvements
• Supervise SOP and TMF management, archiving, CRO vendor assessment, and tracking Pre-Approval Access programs
• 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

Qualifications

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 ability to identify compliant solutions
• Strategic Thinking: Stimulates creativity and innovation in others; open to new ideas
• Project Delivery: provide project status and decision-support information to the Project Team
• Relationship Management: Establish and maintain high-quality relationships across the company
• Act as the single point of contact for UK Medical Research Project needs
• Maintain relationships with third-party vendors and internal/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.