Senior Director, Clinical Operations

Select how often (in days) to receive an alert:

London, United Kingdom | full time | Job

As the (Senior) Director, Clinical Operations UK Country Head, you will play a pivotal role in shaping and executing BioNTech’s clinical research strategy across the United Kingdom. This is a unique opportunity to provide clinical operations leadership to a high-performing team, translating organisational vision into actionable plans that drive excellence in clinical trial delivery. You will be accountable for fostering a culture of innovation, collaboration, and continuous improvement, ensuring that all UK‑based clinical operations activities align with business priorities, regulatory requirements, and the highest standards of quality and integrity.

In this leadership position, you will serve as the primary point of contact for UK clinical operations, building and nurturing relationships with key stakeholders—including government agencies, NHS partners, patient advocacy groups, and local vendors. Your expertise will be instrumental in advancing BioNTech’s ambitious portfolio, supporting groundbreaking initiatives such as the Cancer Vaccine Launchpad and the UK trials network. With a focus on operational excellence, talent development, and strategic partnership, you will help position BioNTech at the forefront of clinical innovation in the UK, delivering impactful therapies to patients and supporting the company’s global mission.

• Accountable for strong leadership, people management, talent retention, and development within the Clinical Operations Team in the UK, providing clear direction and vision.
• Translate the organisation’s vision, mission, and strategy into coherent plans and requirements that can be understood and implemented by clinical research staff.
• Ensure all teams operate according to agreed business priorities, regulatory requirements, and internal processes to deliver excellence in studies and projects.
• Proactively build the culture required to achieve UK ambitions and provide professional clinical operations input to UK partnership initiatives, including the development of the Cancer Vaccine Launchpad and the UK trials network.
• Accountable for the execution and delivery of sponsored human subject research across all therapy areas and development phases in the UK, ensuring quality, timeliness, budget adherence, and resource allocation as defined in study protocols, local regulations, ICH GCP/IND guidelines, and BioNTech standards.
• Supervise project team members’ adherence to regulatory requirements, ICH‑GCP guidelines, and relevant procedures (policies, SOPs, instructions), including the conduct of required training.
• Provide instruction and supervision to local Clinical Operations staff (line management).
• Plan team resources in alignment with the VP, Clinical Operations, ensuring the team’s capabilities are proactively developed to meet future opportunities.
• Develop and implement a resourcing strategy (internal staff and/or external resources) to ensure the availability and competency of resources needed to meet portfolio requirements.
• Cultivate strong relationships with sites, government agencies (e.g., NIHR, MHRA), patient advocacy groups, and local vendors (including but not limited to CROs) at both strategic and operational levels.
• Ensure UK partnership initiatives are fully integrated into clinical trial execution to maximise benefits.
• Actively engage with local partners and regulatory stakeholders to maintain and influence a positive operational environment for clinical trials in the UK.
• Serve as the point of escalation for challenges in project activities involving other sponsor departments or external vendors.
• Lead clinical monitoring oversight for trials executed by strategic partners in the UK.
• Drive business efficiencies, implement new processes (including the Playbook for UK trial execution), and facilitate quality improvement.
• Promote the sharing of best practices, learnings, and expertise at local, regional, or global levels as appropriate.
• Ensure the quality and integrity of clinical trials.
• Actively identify and manage internal and external risks to the…