Senior Manager Biomarker Operations

Summary & Purpose of the Position

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.

Key individual contributor to clinical studies

• 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

Essential:

• 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.

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).

Nous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons « The Real Us ». La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de l'inclusion et de l'égalité des chances.