Director, Applications, Regulated & Commercial Systems

About the role

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/

Key Responsibilities

• Manage a portfolio of business-critical applications used by regulated functions.
• Cook up 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.
• Cook up 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.
• Cook up 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.
• Cook up 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.
• A 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.

Preferred Experience

• MBA, MS, PharmD, PhD, or another advanced degree in a relevant discipline.
• Experience working remotely from the U.S. East Coast.
• Experience collaborating with colleagues across the United States and France.
• Ability to travel occasionally, including periodic visits to Inventiva’s headquarters in Dijon, France.