Senior Manager Biomarker Operations (Biopharma)

TL;DR

Senior Manager Biomarker Operations (Biopharma): Leading the biomarker operations function across the clinical portfolio with an accent on end-to-end workflow design, vendor oversight, and regulatory compliance. Focus on scaling operational capabilities, managing cross-functional teams, and ensuring data integrity for clinical development programs from early to late-stage.

Location: Hybrid role based in Paris or London.

Company

hirify.global is a global biopharmaceutical company focused on transformative medicines in oncology, rare disease, and neuroscience.

What you will do

• Manage and develop a team of biomarker operations managers, setting priorities and resourcing plans.
• Design and optimize end-to-end workflows for assay development, validation, and vendor oversight.
• Lead vendor strategy, performance monitoring, and qualification frameworks.
• Oversee operational delivery for biomarker programs, including study start-up and regulatory filing preparation.
• Ensure data integrity and compliance with GxP, GCP, and GCLP standards.
• Partner with clinical operations, regulatory, and quality teams to integrate biomarker deliverables into clinical plans.

Requirements

• 8-10+ years of experience in biomarker or clinical operations within biopharma, biotech, or CRO environments.
• Proven experience in people leadership, including coaching, performance management, and team development.
• Deep knowledge of immunoassay platforms (e.g., flow cytometry, IHC, proteomics, NGS) and GxP validation.
• Strong understanding of FDA/EMA regulatory expectations for biomarker assays.
• English proficiency is essential; French is a plus.
• Experience in designing and scaling standardized operational workflows in a matrixed environment.

Nice to have

• PhD in a biological science or related technical field.
• Oncology or immuno-oncology biomarker experience.
• Experience with Phase 3 registrational studies and regulatory submissions.
• Proficiency with database systems for sample tracking and data management.

Culture & Benefits

• Commitment to human-centric leadership and a culture of collaboration.
• Opportunities to work on life-changing projects with a direct impact on patients.
• Support for professional growth and empowerment to thrive.
• Inclusive workplace valuing diverse perspectives and experiences.