Ipsen

Company Name: Ipsen
Job Title: Biometric Systems Director F/M
Job Description: Summary / Purpose Of The Position

The Biometric Systems Manager drives successful implementation and use of clinical data management systems (CDMS) and Statistical Computer environment (SCE) in relation to planning, Implementation, Adoption & Maintenance.

The Biometric Systems Manager delivers projects working multidisciplinary teams such as data management, Stats programming, clinical trial excellence team, quality, IT.

He/she manages these biometry systems in compliance with Regulatory, GXP and Business requirements integrating Ipsen processes to ensure internal worldwide deployment, driving a culture of compliance and quality that aligns with ICH/GCP guidelines, regulatory requirements, and internal policies.

Duties include analyzing Biometry Leadership and user requirements, assigning appropriate internal or external resources, overseeing planned and ongoing work to a successful and on time outcome, managing financial requirements and maintaining the highest level of quality. Also, duties include monitoring changes in the business environment, analyzing the Ipsen needs in perspective with new capabilities and proposing roadmap to maintain up-to-date systems and corresponding services.

Main Responsibilities / Job Expectations

System Planning, Implementation, Adoption & Maintenance

He/she is responsible for the technical management of all Biometrics systems.
Support the development of efficient implementation and adoption plans.
Ensure the proper operation of the systems, including compliance to specifications, performance and support.
Initiate continuous improvement efforts, identify, and develop best practices, and enforce standardization throughout system implementation.
Propose system upgrade and contribute to the projects when approved
Ensure implementation and maintenance of the GxP validation status when applicable with IT QA. This includes making sure that validation-related activities are conducted by the team or under the team responsibility when systems are implemented or upgraded (risk analysis, UAT scripts development, UAT scripts execution, maintenance of the validation documentation).
Contribute to the security of the systems with IT security
Ensure compliance with applicable regulations including GDPR
Manage contracts renewals when appropriate
Lead Request For proposal process up to vendor selection and contract execution with vendor.
Users training and business process definition are under System Owner responsibility who may be within the Systems, Standards and Services team.
In addition, the Biometric System Manager maintains competitive intelligence and monitor changes in the pharmaceutical industry environment. He/she analyzes the Ipsen needs, put in perspective with new capabilities and propose a roadmap to keep Ipsen Biometry systems up-to-date and on the top of the art when possible.
Monitor the use of the systems by performing periodic quality checks to identify compliance issues and areas where support and help are most needed.
Provide and monitor metrics and key system indicators (number of connections, etc.)
Oversight the service provider in charge of the system support.
Act as an active Change Advisory Board member providing recommendations for priority of any new enhancements/bug fixes.

Team Management

The Biometric Systems Manager is an effective team manager, responsible for talent development, line management and supervision of team members in his/her group. He/she is responsible for building capabilities and technical skills within his/her group to ensure team efficiency.

He/She recruits, manages, mentors, trains, develops all Systems collaborators and conduct the RH processes including objectives definition, performance review, assessment of development needs. He/She manages the team priorities and its workload.

He/She defines and tracks the budget and the contracts associated to these activities and for temporary staff (if any).

Acquisition of new products or companies

Support the assessment of similar systems/processes used by the acquired companies
Support data integration strategy/plan
Can take over for a transitional period the administration of an equivalent activity while waiting

for a convergence of the processes

EHS Responsibilities

Comply with applicable EHS regulations and procedures.
Participate in the site's EHS performance by reporting risks, malfunctions or improvements
Participate in mandatory EHS training

Knowledge, Abilities & Experience

Education / Certifications:

Bachelor’s degree in life sciences, information technology, or related field

Experience

Successful experience in the implementation/management of biometric systems

Strong experience in GXP system validation processes

Demonstrate initiative, problem solving mindset, sound judgment and flexibility; possess effective time management and organizational skills; and be able to work under deadlines and on multiple projects simultaneously.

Understanding of Information Security / data privacy principles to ensure compliant handling and management of data.

Ability to develop and implement a system implementation strategy.

Experience in oversight subcontracting activities with a vendor

In-depth knowledge of international standards (ICH, GCP) and other regulatory and legal requirements having an impact on the development and maintenance of systems used in clinical development.

Collaborative team player, professional demeanor, enthusiastic, and self-motivated

Ability to work effectively in a matrix organization.

Ability to communicate effectively with senior management as well as with peers

Excellent oral and written communication skills.

Ability to produce high quality, accurate work to meet deadline. (Strong planning skills)

Languages: Fluent English

Key Technical Competencies Required

Good knowledge of international standards (ICH, GCP, GAMP …)

Good knowledge of systems used in drug development (SAS, Datawarehouse, Data Lake, CDMS)

Up to date on regulations regarding clinical data collection such as: GCP (Good Clinical Practice), 21 CFR part 11,

GCDMP (Good Clinical Data Management Practices) and GDPR (General Data Protection Regulation)

Good experience in validating GXP systems

Good knowledge of project management methods

Boulogne-Billancourt, France

Remote

26-03-2025

Company Name: Ipsen
Job Title: Principal Statistical Programmer F/M
Job Description: Purpose of the position

The Principal Statistical Programmer will participate in production/QC programming, project coordination, CRO

management and oversight of vendor programming across Ipsen rare disease studies.

Main Responsabilities

To ensure the efficiency and quality of biometry deliverables; ensure that all clinical datasets meet the

standards required for regulatory submissions for all INDs and NDAs/MAAs;

Responsible for Statistical Programming activities, including analyzing, integrating and reporting of clinical trial data in order to produce quality and timely deliverables; perform data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data;
Provide statistical programming support to generate derived analysis data sets, tables, listings, and figures for Clinical Study Reports, regulatory submissions, annual IND safety update reports and Integrated summaries (ISS/ISE); create/QC of CDISC SDTM and ADaM files, SAS export files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources;
Complete full QC validation of in-house created graphs/tables/figures and interact with Statisticians, Programmers and other members of the clinical team, perform ad hoc analysis and generate outputs according to the requirements;
Review and comment on CRFs, annotated CRFs, Data Management Plan, Data validation plan, edit check specifications and study related documents; participate in operations meetings and address issues that may influence statistical programming and data management;
Work with CRO statisticians, statistical programmers and review/QC their work/deliveries; understand clinical trial design and reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation; and, execute and manage multiple simultaneous projects and deadlines with shifting priorities and resources in a fast-paced working environment.

Knowledge & Experience

Proficiency in statistical programming package(s), SAS is required;
Familiar with Global Clinical Data Interchange Standards Consortium (CDISC);
Experience in SDTM and ADaM specification and programming;
Experience in reporting and TFL programming.
5+ years’ programming experience in pharmaceutical/biotech/CRO environment in drug discovery/clinical trials / drug development

Knowledge & Experience

R or other packages are desired

Education / Certifications

Bachelor or MSc in Statistics, Mathematics, or Scientific Discipline

Education / Certifications

Language

English

Boulogne-Billancourt, France

Remote

26-03-2025

Company Name: Ipsen
Job Title: Scientist 1
Job Description: Ipsen is currently recruiting for an Analytical Development Scientist to join their Biologics Development team at the Wrexham site. This is a 12-month fixed-term contract that offers the chance to be part of a growing global organization and make a significant impact on people's lives. Ipsen is heavily investing in the Wrexham site, with brand new, state-of-the-art Biologics Development laboratories and production facilities.

The successful applicant will have the opportunity to learn a variety of skills through self-driven personal development and will be required to support both internal and external activities of Ipsen's developing pipeline. The role involves analytical method development using techniques such as ELISA, U/HPLC, capillary isoelectric focusing (cIEF), IEF, SDS-capillary electrophoresis (SDS-CE), and CE-based immunoassays

Role Responsibilities

Deliver effective analytical testing for the development of novel biologic products from Phase I to Phase III, including in-process and characterisation, pre-clinical and clinical batch release and stability testing in support of our product quality.
Utilising techniques within the scope of the analytical development team deliverables such as but not limited to; basic physical/ chemical properties (pH, moisture, container closure), quantitative analysis by HPLC, plate-based immunodetection assays (e.g. ELISA), purity techniques such as HPSEC, capillary isoelectric focusing (cIEF) and SDS-capillary electrophoresis (SDS-CE). Apply understanding of Analytical development to execute activities & interpret results.
Keeping actuate GMP records, evaluating data and where appropriate present findings at relevant forums/ meetings
Assist in the operation and maintenance of the Analytical development group (general lab processes and activities e.g. sample management, inventories, equipment cleaning and daily calibrations)
Work collaboratively across Biologic Development areas to support execution of studies and analysis of results
Work collaboratively to develop process and SOP updates to drive regulatory compliance.
Assist in regulatory documentation as required.
Actively participate in meetings (listens, shares questions and ideas)
Effectively communicate progress with cross-functional teams and escalate issues as needed present information and data at internal meetings.

Requirements For The Role

Biopharmaceutical R&D industry experience working in technical team(s) desired.
Knowledge and technical capabilities desirable in at least one of the primary activities/ core areas to support the development, implementation, validation, and lot release testing for biologics products.
Ability to work independently according to established methods and SOPs to perform analytical testing as required.
Ability to work in diverse and multi-cultural technical team, to advance technical areas of responsibility through cross-functional working and maintenance of scientific literature awareness and competency.
Knowledge of ICH Guidelines and working to GMP/GLP standards

Wrexham, United Kingdom

On site

01-04-2025

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