Senior Study Manager - Immunology

THE ROLE

As Senior Study Manager, you will provide scientific and operational leadership across customer studies, ensuring routine, complex and developmental projects are delivered to a consistently high standard. You will translate customer objectives into robust study designs, practical workplans, meaningful data outputs and clear, client-ready communication.

This role is suited to an experienced scientific professional with proven expertise in managing complex studies, who is ready to take greater ownership of study delivery, scientific oversight and customer relationships. You will confidently lead studies from concept to completion, balancing scientific quality, timelines and commercial objectives, while providing guidance, mentorship and support to direct reports to enable their development and success.

You will be highly organised, managing multiple studies, priorities and stakeholders simultaneously, while proactively identifying and mitigating study risks, technical challenges, resource constraints and documentation needs. You will communicate complex scientific and operational information clearly to both customers and internal teams and support data interpretation, quality standards, team development and continuous improvement across study delivery.

As a key member of the scientific unit, you will contribute to the ongoing development of capabilities, processes and ways of working within your assigned area, helping shape scientific strategy and support the growth of RoukenBio’s services.

The ideal candidate combines strong scientific judgement with excellent organisational skills, a proactive, customer-focused approach and the ability to coach others, helping maintain RoukenBio's reputation for scientific excellence, quality and collaborative service.

WHAT WE EXPECT YOU TO DO

Key responsibilities:
Study leadership delivery & scientific management

• Lead routine, complex and developmental customer studies from initiation to completion, ensuring customer objectives, scientific quality, timelines, budgets and deliverables are achieved.

• Oversee multiple studies and customers simultaneously, providing scientific leadership and ensuring consistent, high-quality study delivery.

• Design robust, deliverable study plans and provide scientifically informed recommendations that balance customer needs with operational feasibility.

• Directly manage complex or strategic projects where required and proactively identify and mitigate scientific, operational and resource risks.

• Build trusted customer relationships through clear communication, regular scientific updates and effective management of study progress and expectations.

• Allocate studies appropriately, providing technical guidance and mentoring to Study Managers and Study Scientists to support high-quality delivery and professional development.

• Line manage direct reports by setting objectives, conducting performance and development reviews, and supporting training and career progression.

• Collaborate with operational teams to optimise study timelines, resource planning and laboratory capacity, ensuring efficient project execution.

• Drive continuous improvement across study management processes, systems and workflows, contributing to the development of your scientific unit.

• Support the delivery of revenue targets and project milestones for directly and indirectly managed studies, contributing to the commercial success of the business.

Scientific oversight, interpretation and troubleshooting

• Apply strong assay knowledge to support practical study design, data interpretation and robust scientific conclusions.

• Interpret data as it is produced to identify good results, emerging issues and the need for prompt troubleshooting or study adaptation.

• Proactively mitigate potential errors by identifying likely assay, procedural, reagent, equipment or documentation risks.

• Support troubleshooting of assays, procedures and study outputs, drawing on wider technical awareness and the needs of the customer question.

Team coordination, training and operational planning

• Coordinate study teams so that operators and contributors understand the customer needs, study plan, quality expectations and the reason behind the work.

• Support scheduling and prioritisation of study activities, balancing customer milestones with people, equipment, reagent and laboratory capacity.

• Train and support colleagues in routine to complex assays, study processes and documentation expectations to maintain consistent standards.

• Contribute to long-term assay readiness by proactively considering reagent supply, assay performance, training requirements and future project needs.

Documentation, quality and compliance

• Prepare and review clear protocols, analysis plans, reports, data updates and customer communications that accurately describe the study plan, progress and outcome.

• Conduct thorough technical review of study documentation, actively checking scientific accuracy, completeness, consistency and data integrity.

• Promote strong documentation practice through GDocP and ALCOA+ principles, keeping training current and supporting the timely completion of quality events, deviations, change controls, risk assessments and audit responses where relevant.

• Challenge poor practice constructively and support high standards of laboratory organisation, health and safety and quality compliance.

Customer, commercial and continuous improvement support

• Build trusted customer relationships through clear communication, proactive issue management and scientifically sound recommendations, identifying opportunities to enhance customer value and support future business.

• Act as a scientific subject matter expert, partnering with the Sales Lead and customers to design robust, deliverable studies that align customer objectives with RoukenBio's scientific capabilities and operational capacity. Lead the technical aspects of project discussions and provide realistic expectations on study scope, timelines and deliverables.

• Support business development by contributing scientific and study management expertise to customer discussions, proposals, technical responses, contracts and change orders, ensuring commercially viable solutions and transparent project costings.

• Drive continuous improvement by identifying opportunities to enhance systems, processes, study workflows and training, improving quality, efficiency, consistency and commercial performance.

• Champion a collaborative, solutions-focused culture that embraces innovation, continuous improvement and resilience, supporting both team success and the strategic growth of the business.
  
  Key Competencies:

• Senior-level study management;

• complex study delivery;

• strong scientific and assay understanding;

• data interpretation and troubleshooting;

• customer communication;

• technical review and scientific writing;

• writing, reviewing: GDocP, ALCOA+ and quality compliance;

• team training and coordination; multi-study prioritisation;

• commercial awareness;

• continuous improvement;

• collaboration and emotional intelligence.

WHAT WE ARE LOOKING FOR FROM YOU

We would like you to have the following:

• A PhD in immunology, or a related life-science discipline; or an MSc with several years of experience. A prior experience in Allergy & inflammation field is advantageous but not essential, provided candidates can demonstrate comparable scientific knowledge and practical expertise.

• Significant experience managing customer or client-facing scientific studies within a CRO, biotechnology, pharmaceutical, translational immunology or laboratory-based research environment.

• A strong track record of managing multiple studies simultaneously, including complex or developmental work, while maintaining customer timelines and scientific quality.

• Strong understanding of assay background, study design, data analysis, data checks and interpretation of study results.

• Experience preparing and reviewing study documentation, including protocols, analysis plans, reports, customer updates and technical communications.

• Good working knowledge of quality expectations relevant to laboratory studies, including GDocP, ALCOA+ principles, training compliance and quality-event processes.

• Confidence communicating with customers and internal stakeholders, including the ability to explain complex scientific information clearly and make appropriate recommendations.

• Evidence of training, mentoring or coordinating colleagues to support consistent study delivery and high laboratory standards.

• Strong organisational judgement, with the ability to prioritise, adapt and remain constructive when study needs or customer priorities change.

• A proactive approach to continuous improvement, best practice sharing and identifying practical solutions to scientific or operational challenges.
  To support a culture within RoukenBio which is aligned to our company values and behaviours, we would like you to be:

• Self-motivated, highly organised and able to take ownership while supporting wider team productivity.

• Approachable and collaborative, encouraging colleagues and stakeholders to ask questions, raise concerns and contribute ideas.

• Goal-oriented and able to deliver success for both self and the wider team within required timescales.

• Adaptable, resilient and creative in response to changing priorities, while maintaining scientific integrity and customer focus.

• An excellent communicator who builds effective relationships externally and internally at all levels of the business.

• Committed to self-learning, mentoring others and sharing best practice to support employee development.

• Solutions driven, quality focused and attentive to detail, with a continuous-improvement mindset.

• Customer focused, with the needs and requirements of customers at the heart of what you do.

WHAT YOU’LL GET FROM US

You will get the chance to learn, grow, develop, and enhance your career within a biotechnology company at the forefront of drug development strategies. In addition, the company offers the following benefits package:

• Competitive salary: £47,544-£49,921, depending on experience.

• Pension.

• 32 days holiday per annum (inclusive of public holidays) which increases to a maximum of 37.

• Death in Service Benefit which includes access to a 24/7 virtual GP.

• Flexible working.

• Refer a Friend Scheme.

• On-site car parking.

• Free Healthy Snacks.

• Merit Award Recognition Scheme.

• The opportunity to join several committees or focus groups (Employee Engagement, Wellness, Recognition, Health & Safety or Social Committee).