At a Glance
- Tasks: Lead biomarker operations and drive strategic initiatives across clinical development.
- Company: Ipsen, a leader in biopharma with a commitment to innovation.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Join a dynamic team dedicated to advancing medical science and patient care.
- Why this job: Make a real impact in clinical research and shape the future of healthcare.
- Qualifications: 8-10 years in biomarker operations with strong leadership and problem-solving skills.
The predicted salary is between 70000 - 90000 € per year.
The Senior Manager Biomarker Operations is a strategic and operational leader responsible for driving the biomarker operations function across Ipsen’s portfolio. This role oversees a team of Biomarker Operations Managers and ensures the successful execution of biomarker and bioanalytical strategies that support clinical development from early to late-stage programs, including multiple registrational studies. Reporting directly to the Head of Clinical Biomarkers, this role is a key interface with cross-functional stakeholders, including Clinical Biomarkers, Clinical Operations, Biometrics, Clinical Pharmacology, Regulatory, Quality and other internal and external partners.
Main Responsibilities & Technical Competencies
- Define and drive the biomarker operations strategy.
- Manage and develop a team of manager-level direct reports (hiring, coaching, performance management, succession planning), setting clear priorities and resourcing plans across the portfolio.
- Design and continuously improve end-to-end workflows (assay development/validation, vendor oversight), embedding fit-for-purpose governance, KPIs, and inspection readiness.
- Lead vendor strategy and performance management, overseeing qualification and establishing performance monitoring frameworks to drive accountability and quality across external partnerships.
- Provide budget and resource stewardship: consolidate forecasts across studies, track external spending, and align headcount/contracting to program needs.
- Develop knowledge assets (playbooks, SOPs, training) to build organizational capability and consistency.
- Drive process improvement and operational scale-up: identify areas for improvement, centralize tasks, automate where appropriate, and implement metrics dashboards to improve speed, quality, and compliance.
- Lead continuous improvement initiatives to reduce operational burden and enhance scalability across programs; steward change-management and adoption across teams.
- Establish role clarity and ways of working across Biomarker Leads, Clinical Operations, Regulatory, and vendors; simplify handoffs, decision rights, and cross-functional interfaces.
- Partner closely with Clinical Operations, Regulatory, Quality, Data Management, and external labs to ensure biomarker operations are optimally integrated into clinical development plans and submissions.
- Own operational delivery for multiple biomarker programs across early-late stage development, partnering with Biomarker Leads to ensure data quality, timelines, and regulatory alignment.
- Contribute personally to key study start-up, interim/readout activities, and regulatory filing preparation.
- Drive biomarker study start-up activities including lab manual development, central lab RFP review, and coordination of vendor onboarding; apply and refine portfolio-level templates.
- Oversee sample lifecycle management (planning, tracking, logistics, deviations, queries) and lead escalation/mitigation for issues impacting samples or data.
- Accountable for biobanking operations (reconciliation; eCRF/ICF compliance; future research samples) and ensuring accurate documentation in eTMF.
- Ensure data integrity by defining and applying systematic data checks/cleaning processes for biomarker sample and assay data; implement portfolio-level data conventions and DTA standards.
Knowledge & Experience
- 8-10+ years in biomarker/clinical operations (biopharma/biotech/CRO) covering global studies; hands-on program execution (assay readiness, troubleshooting, sample ops, study start up).
- Extensive experience designing, implementing, and scaling standardized workflows, knowledge-management systems, and efficiency tools to support consistent biomarker operations in a matrixed environment.
- Proven experience leading operational aspects of biomarker programs across early and late-stage clinical development, including assay readiness for clinical trials, troubleshooting complex performance issues.
- People leadership: proven experience managing teams (supporting day to day issues, setting priorities, coaching, succession planning) while contributing personally to program delivery.
- Deep knowledge of immunoassay platforms (e.g., flow cytometry, IHC, proteomics, NGS) and validation under GxP; ability to interpret performance data and drive corrective actions.
- Strong working knowledge of FDA/EMA expectations for biomarker assays; GCP/GCLP compliance; documentation that is submission-ready.
- Track record qualifying/overseeing CROs and specialty labs performance management and issue escalation.
- Evidence of cross-functional integration with Clinical Ops, Regulatory, Quality, and Data Management to align biomarker deliverables to clinical plans and regulatory filings.
Knowledge & Experience (preferred)
- Experience working in matrixed environments and driving operational improvements.
- Demonstrated ability to balance execution with process-building.
- Strong problem-solving (technical, operational, vendor oversight), project management, and collaboration skills.
- Oncology / immuno-oncology biomarker experience.
- Registrational/Phase 3 exposure and demonstrated contribution to regulatory submissions.
- Experience with database systems for sample tracking and data management.
Education / Certifications
- Bachelor’s degree in a biological science or related field with 10+ years experience or advanced degree with 8+ years experience.
- PhD in a biological science or related technical field with 8+ years experience (preferred).
Senior Manager Biomarker Operations in London employer: Ipsen
Ipsen is an exceptional employer that fosters a collaborative and inclusive work culture, where every employee's voice is valued. With a strong focus on professional development, employees in the Senior Manager Biomarker Operations role will benefit from comprehensive training and growth opportunities while working on cutting-edge biomarker strategies that directly impact clinical development. Located in a vibrant area, Ipsen offers a dynamic environment that encourages innovation and teamwork, making it an ideal place for those seeking meaningful and rewarding careers in biopharma.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager Biomarker Operations in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the biomarker and clinical operations space. Attend industry events or webinars, and don’t be shy about introducing yourself. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for interviews by diving deep into the company’s projects and values. Show us that you’re not just another candidate; demonstrate your passion for biomarker operations and how your experience aligns with their goals. Tailor your responses to highlight relevant achievements.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors. Focus on articulating your experience in managing teams and driving operational strategies. This will help you feel more confident and articulate during the real deal.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search. So, get your CV ready and hit that apply button!
We think you need these skills to ace Senior Manager Biomarker Operations in London
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience in biomarker operations. We want to see how your skills align with the role, so don’t hold back on showcasing your relevant achievements!
Showcase Your Leadership Skills:As a Senior Manager, we’re looking for someone who can lead a team effectively. Share examples of how you’ve managed teams, set priorities, and driven performance improvements in your previous roles.
Be Clear and Concise:When writing your application, keep it straightforward. Use clear language and avoid jargon where possible. We appreciate a well-structured application that gets straight to the point!
Apply Through Our Website:We encourage you to submit your application through our website. It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it’s super easy!
How to prepare for a job interview at Ipsen
✨Know Your Biomarker Operations Inside Out
Make sure you’re well-versed in the latest trends and technologies in biomarker operations. Brush up on your knowledge of immunoassay platforms and regulatory expectations, as these will likely come up during the interview.
✨Showcase Your Leadership Skills
Prepare to discuss your experience managing teams and driving operational improvements. Be ready to share specific examples of how you've coached team members or handled performance management in previous roles.
✨Demonstrate Cross-Functional Collaboration
Highlight your experience working with various departments like Clinical Operations, Regulatory, and Quality. Prepare anecdotes that illustrate how you’ve successfully integrated biomarker deliverables into clinical plans.
✨Be Ready for Problem-Solving Scenarios
Expect to face hypothetical scenarios related to troubleshooting complex performance issues or improving workflows. Think through your approach to problem-solving and be prepared to articulate your thought process clearly.
