• Office based in Maidenhead (hybrid working model 3 days in office)
• Reporting to the Head of Medical Operations
• Newly created leadership role at Abb Vie UK: excellent compensation and benefits package, with great opportunities to develop your career

Job 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 strong 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
• As an active contributor to cross-functional teams and/or working in matrix organizations will be 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 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 Thinking:

• Stimulates creativity and innovation in others. Open to new ideas

. Project Delivery:

• Communicate project progress by producing project reports to provide timely and accurate project status and decision support information to Project Team.

Relationship Management:

• Establish 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 needs
• Responsible for maintaining relationships with our third-party vendors and internal and external stakeholders.
• Experience in line management

Abb Vie 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

Abb Vie'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 Abb Vie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.