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Senior Manager Biomarker Operations

Ipsen Innovation (SAS) -
Paris (75)

Soumettre votre candidature

Détails de l'emploi

Temps plein

Qualifications

Français
Niveau Doctorat
Anglais
Niveau Licence
Leadership

Description complète du poste

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; 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.

HOW - Behavioural Competencies Required

Think Big - Anticipates scale needs; spots opportunities to standardize, automate, and future‑proof 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; hands‑on program execution (assay readiness, troubleshooting, sample ops, study stat 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 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 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 (essential):

Bachelor’s 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

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. Lorsque nous intégrons des modes de pensée diversifiés, nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble, nous nous efforçons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin d'aménagements ou d'aide pendant le processus de candidature, veuillez en informer l'équipe de recrutement. Ces informations seront traitées avec soin et n'auront aucune incidence sur le résultat de votre candidature. *Soyons nous-même

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Je souhaite recevoir la dernière alerte Emploi pour les postes de ce type : gcp/big data (paris, a8)

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WHAT - Summary & Purpose of the Position

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; 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.

HOW - Behavioural Competencies Required

Think Big - Anticipates scale needs; spots opportunities to standardize, automate, and future‑proof 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; hands‑on program execution (assay readiness, troubleshooting, sample ops, study stat 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 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 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 (essential):

Bachelor’s 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