Director, Regulated & Commercial Applications

Inventiva; United States; Híbrido; USD 110.000 - 160.000; Jornada completa

Descripción de la vacante

Inventiva Pharma is seeking an experienced Application Manager to join its US East Coast-based IT applications team. The role focuses on regulated business applications across Clinical Operations, Regulatory Affairs, Quality, and Pharmacovigilance, with future involvement in CRM platform implementation and commercial systems.

The candidate will work with stakeholders in the United States and Europe, ensuring systems are reliable, compliant, and aligned with evolving business needs.

Formación

• CRM experience is a strong asset for this role.
• Experience with Clinical, Regulatory, Quality or Pharmacovigilance applications.
• GxP requirements, Computer System Validation, 21 CFR Part 11 and Annex 11 knowledge.
• Experience with SaaS solutions and external software vendors.
• Exposure to CRM platforms in healthcare/biotech/pharma environments.
• Strong organizational skills and ability to manage multiple priorities.
• Excellent communication and a pragmatic, service-oriented approach.

Responsabilidades

• Manage a portfolio of business-critical applications used by regulated functions.
• Coordinate lifecycle activities including upgrades, vendor releases, testing and user support.
• Ensure systems remain fit for purpose and meet business requirements.
• Act as primary liaison between business users, vendors and IT for assigned applications.
• Ensure systems are operated in accordance with GxP requirements.
• Coordinate validation, change controls, risk assessments and periodic reviews.
• Maintain documentation and audit readiness.
• Participate in inspections and audits involving IT-controlled systems.
• Build relationships with Quality, Regulatory Affairs, Clinical Operations, Pharmacovigilance and Medical Affairs.
• Translate business needs into practical system improvements and solutions.

Conocimientos

CRM experience

GxP compliance

21 CFR Part 11

Annex 11

SaaS solutions

Vendor management

CRM platforms

Organizational skills

Communication skills

Educación

Bachelor’s in Information Technology, Computer Science, Software Engineering, Information Systems or a related technical discipline

Descripción del empleo

Inventiva is a clinical-stage biopharmaceutical company headquartered in France, focused on the development of lanifibranor in a Phase 3 trial, NATiV3, in MASH. To learn more, please visit: https://inventivapharma.com/

The Opportunity

As part of this evolution, the IT organization is reinforcing its applications team with the recruitment of an experienced Application Manager based on the US East Coast.

The successful candidate will primarily support business applications used by regulated functions such as Clinical Operations, Regulatory Affairs, Quality and Pharmacovigilance. Over time, the role will also contribute to the implementation and management of the future CRM platform and associated commercial systems.

Reporting directly to the IT Director, the Director, Applications will join an existing applications team composed of two specialists based in France.

The role combines application ownership, business support, compliance oversight and project delivery. The successful candidate will work closely with business stakeholders in both the United States and Europe to ensure systems remain reliable, compliant and aligned with evolving business requirements.

This position is particularly well suited to someone who has already managed GxP-regulated applications within a biotech, pharmaceutical or broader life sciences environment and who enjoys working in a relatively lean organization where autonomy and pragmatism are important.

Key Responsibilities

• Manage a portfolio of business-critical applications used by regulated functions.
• Coordinate application lifecycle activities including upgrades, vendor releases, testing and user support.
• Ensure systems remain fit for purpose and continue to meet business requirements.
• Act as the main point of contact between business users, vendors and the IT team for assigned applications.
• Ensure systems are operated in accordance with applicable GxP requirements.
• Coordinate validation activities, change controls, risk assessments and periodic reviews when required.
• Maintain appropriate documentation and support audit readiness.
• Participate in inspections and audits involving IT-controlled systems.
• Build strong relationships with Quality, Regulatory Affairs, Clinical Operations, Pharmacovigilance and Medical Affairs teams.
• Understand business needs and help translate them into practical system improvements.
• Challenge requests when necessary and help stakeholders identify the most appropriate solutions.
• Supporting the selection and implementation of a CRM platform.
• Coordinating business requirements with Commercial and Medical Affairs teams.
• Participating in validation and deployment activities.
• Supporting the long-term administration and evolution of the CRM environment.
• Lead or contribute to application projects.
• Coordinate external partners and software vendors.
• Identify opportunities to simplify processes and improve user experience.
• Contribute to the evolution of the overall applications landscape.

Qualifications

• Previous CRM experience is therefore considered a strong asset for this role.
• Experience working with Clinical, Regulatory, Quality or Pharmacovigilance applications.
• Good understanding of GxP requirements, Computer System Validation, 21 CFR Part 11 and Annex 11.
• Experience working with Clinical, Regulatory, Quality or Pharmacovigilance applications.
• Previous experience in biotech, pharmaceuticals, medical devices or another regulated life sciences sector.
• Experience working with SaaS solutions and external software vendors.
• Exposure to CRM platforms, ideally within a healthcare, biotech or pharmaceutical environment.
• Strong organizational skills and the ability to manage multiple priorities simultaneously.
• Excellent communication skills and a pragmatic, service-oriented approach.
• Comfortable working independently in a remote environment while remaining closely connected with teams based in different locations.
• Bachelor’s in Information Technology, Computer Science, Software Engineering, Information Systems or a related technical discipline

Preferred Experience

WHY JOIN US

Join Inventiva at a pivotal moment as we prepare for the next phase of growth. This is a unique opportunity to lead the strategy and evolution of regulated and commercial applications—building secure, scalable, and compliant systems that support late-stage development, commercialization, and the future growth of a global biotech company.

All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factor prohibited by law.