Director, Evidence Generation Operations

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For more than 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 46 countries and serve 160 countries with the support of a large distribution network.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.

You will manage and lead a team of Clinical Research Scientists in the performance of their duties and responsibilities, providing direction, support, and mentorship to ensure effective clinical study execution according to the defined plans, and in compliance with study protocols and regulations.

You will provide clinical operational leadership in contributing to clinical strategy, goal and milestone setting as part of clinical study planning. 

This role is crucial in maintaining bioMérieux commitment to operational and scientific excellence and patient-centric approaches within the competitive global healthcare landscape.

Specific duties include eight key areas:

Strategic Leadership:

• Develops clinical operational strategy(ies), sets goals and milestones, and provides input on the operational components of study and trial design as part of clinical evidence generation

Team Leadership:

• Set clear priorities and performance expectations aligned with global evidence generation strategy
• Manage and mentor direct reports
• Promote accountability and continuous improvement within the clinical operations team
• Oversee resource planning and allocation to manage studies within the evidence generation portfolio
• Act as central point of contact for issues escalation in the conduct of clinical studies in the assigned regions

Project Management and Clinical Trial and Program Oversight:

• Oversee the implementation, management, and tactical execution of clinical trial operational plans by responsible team members including Clinical Research Scientists (CRS) and logistics. Oversee trail execution, ensuring clinical trial programs and individual trials deliverables are met and are conducted on time, within budget, and in compliance with all SOPs, GCP, ICH guidelines, and any other country or regional regulations
• Proactively manage risk, escalation, issue resolution, and manage aggregate timelines and resources

Vendor & Site Management:

• Lead the selection, contracting, and oversight of clinical trial vendors (CROs, investigators, labs, and other suppliers)
• Mentor clinical research scientists to serve as the primary liaison and relationship manager for vendors and other partners
• Review vendor performance and support the CRS in the negotiation of contracts and performance metrics as required

Quality & Compliance:

• Establishes quality guidelines
• Monitor activities and ensure adherence to Good Clinical Practices (GCP) and ICH guidelines
• Ensure inspection readiness for clinical trials
• Perform quality assurance checks and provide coaching / mentoring
• Monitor and evaluate clinical trial data to ensure safety and compliance
• Assure quality and compliance support corporate goals and evidence requirements

Cross-functional Collaboration:

• Collaborate closely with cross-functional teams to ensure timely delivery of the studies within the Evidence Generation Plan(s) including: Disease State Scientists, Logistics, Vendor Management, Regional Medical Affairs, Biostatistics and Data Management, Strategy and Insights Gathering, Medical Affairs Operations, Medical Writing, Market Access, Marketing, Regulatory, Finance, Legal

Process Improvement:

• Define best practices, processes and procedures for conducting clinical trials in Medical Evidence Generation, and document those in Standard Operating Procedures (SOP), Work Instructions (WI), or Guidelines
• Implements best practices in clinical study and trial execution while assuring consistency in practice across the Global Medical Affairs organization in all franchises
• Implement and oversee the use of systems for clinical trial management to assure project and study tracking, reporting and dashboarding

Communicating and Reporting:

• Assures stakeholders are regularly updated on program and study status, budget compliance, alignment or changes in timelines and milestones, and any risks identified for projects, planned, ongoing, or complete

What is your profile?

• Bachelor’s degree in microbiology, Molecular Biology, Life Sciences, or Biomedical. Master’s or PhD is strongly preferred
• 8+ years in clinical trials / clinical trial operations, with significant management experience in pharma/biotech/med device, especially in diagnostics or relevant therapeutic areas (e.g., microbiology, immunology or molecular or infectious diseases)
• Direct management experience
• Deep expertise in clinical research operations, including clinical trial protocol design (complex studies), and strong knowledge of GCP, ICH guidelines, and quality assurance standards
• Proven project and portfolio management capability, with the ability to lead complex clinical studies, manage competing priorities, and deliver against timelines, budgets, and quality expectations
• Strong operational and financial acumen, including budget management, resource allocation, and risk mitigation across study programs
• Solid understanding of relevant diagnostic technologies (e.g., molecular diagnostics, immunoassays, antimicrobial susceptibility testing) and their application in clinical evidence generation
• Demonstrated leadership capability with experience leading, developing, and inspiring high-performing teams, fostering accountability, collaboration, and continuous improvement
• Strong cross-functional leadership and influencing skills, with the ability to align diverse stakeholders in a global, matrixed environment to ensure successful study execution
• Excellent communication skills and executive presence, with the ability to clearly convey complex clinical and operational information to senior stakeholders and drive informed decision-making
• Ability to drive operational excellence through process improvement, standardization, and effective use of metrics and governance

Approximately 10% travel required

bioMérieux welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.