Senior Manager Biomarker Operations

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology Rare Disease and Neuroscience. Supported by nearly 100 years of development experience with global hubs in the U.S. France and the U.K we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration excellence and impact. At Ipsen every individual is empowered to be their true selves grow and thrive alongside the companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!

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WHAT - Summary & Purpose of the Position

The Senior manager Biomarker Operations is a strategic and operational leader responsible for driving the biomarker operations function across Ipsens 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 theHead 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.

WHAT - Main Responsibilities & Technical Competencies

Define and drive the biomarker operations strategy:

• Manage and develop a team of managerlevel direct reports (hiring coaching performance management succession planning) setting clear priorities and resourcing plans across the portfolio.

• Design and continuously improve endtoend workflows (assay development/validation vendor oversight) embedding fitforpurpose 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 scaleup: 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 changemanagement and adoption across teams.

• Establish role clarity and ways of working across Biomarker Leads Clinical Operations Regulatory and vendors; simplify handoffs decision rights and crossfunctional 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.

Key individual contributor to clinical studies:

• Own operational delivery for multiple biomarker programs across earlylate stage development partnering with Biomarker Leads to ensure data quality timelines and regulatory alignment.

• Contribute personally to key study startup interim/readout activities and regulatory filing preparation.

• Drive biomarker study startup activities including lab manual development central lab RFP review and coordination of vendor onboarding; apply and refine portfoliolevel 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 portfoliolevel data conventions and DTA standards.

HOW - Behavioural Competencies Required

Think Big - Anticipates scale needs; spots opportunities to standardize automate and futureproof operations

Act Together with Passion - Builds strong collaborative relationships across functions (biomarker leads clinical ops regulatory vendors) and inspires trust. Communicates with clarity and enthusiasm to align teams toward common goals.

Execute with Precision - Maintains a high level of rigor and attention to detail in operational delivery. Ensures compliance with regulatory standards while driving efficiency and quality.

Trust Each Other - Operates with integrity and transparency fostering an environment of mutual respect and shared success.

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• 8-10 years in biomarker/clinical operations (biopharma/biotech/CRO) covering global studies; handson program execution (assay readiness troubleshooting sample ops study stat up).

• Extensive experience designing implementing and scaling standardized workflows knowledgemanagement 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 and

• 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 submissionready.

• Track record qualifying/overseeing CROs and specialty labs performance management and issue escalation.

• Evidence of crossfunctional 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 / immunooncology biomarker experience.

• Registrational/Phase 3 exposure and demonstrated contribution to regulatory submissions.

• Experience with database systems for sample tracking and data management

Education / Certifications (essential):

• Bachelors degree in a biological science or related field with 10 years experience or advanced degree with 8 years experience

Education / Certifications (preferred):

• PhD in a biological science or related technical field with 8 years experience

Language(s) (essential):

• English

Language(s) (preferred):

• French

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