Senior Manager Biomarker Operations

Title:

Senior Manager Biomarker Operations

Company:

Ipsen Innovation (SAS)

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 company's success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at  and follow our latest news on Linked In and Instagram.

Job Description:

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 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.

WHAT - 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;…