Joel Guidoux

Accomplished and results-driven Director of Clinical Operations & Development with over 25 years of experience leading global clinical programs with medicinal products, medical devices, and cell therapies. Proven expertise in strategic planning, budget oversight, and team leadership, with a track record of successfully managing complex programs from Phases I-III. A senior clinical spokesperson used to fast-paced environments and driven by quality, work ethics and strategic business objectives.

Consultant, Clinical Development and Operations at Self-employed (2025-01 – Present)

Director of Clinical Operations & Development at AB SCIENCE (2022-10 – 2024-10)

Products: masitinib (TK inhibitor), AB8939 (microtubule destabilizing agent)

• Led and executed 11 global clinical programs (Phases I-III) across a diverse portfolio within set timelines and budget, and despite resources and financial limitations.
• Managed and mentored a clinical department of 25 full-time employees, promoting a culture of high performance and operational excellence.
• Oversaw strategic partnerships with 15+ CROs, optimizing vendor performance and collaboration.
• Provided key strategic guidance on clinical development and acted as a senior clinical spokesperson in internal and external meetings.
• Implemented process improvements and maintained compliance, ensuring inspection readiness and adherence to quality standards.
• Accountable for clinical trial budgets in the range of €40-50M per Phase III trial.

Consultant, Clinical Development and Operations at Self-employed (2021-11 – 2022-10)

Director, Clinical Operations & Strategic Planning at ILTOO PHARMA (2017-03 – 2021-04)

Product: ILT-101 (low-dose IL2)

• Set up and executed clinical programs, leading a team of 3 Clinical Project Managers.
• Developed the clinical development strategy, including a path to MAA/BLA approval in the EU and US.
• Managed all clinical trial vendors and CROs, and prepared for and chaired Steering Committee and DSMB meetings.
• Completed enrolment, data cleaning and statistical analysis of a phase II SLE program per timelines agreed with the company's business partner (Servier).
• Acted as the company's representative for external stakeholders, including business partners and academic consortiums (INSERM, CNRS, Sorbonne University, AP-HP, MGP).
• Managed clinical program budgets, including long-range planning, and provided support for due diligence processes.

Head of Clinical & Regulatory Affairs at CELLCOTEC B.V. / ORTEQ SPORTS MEDICINE (2009-08 – 2017-02)

Products: INSTRUCT/CartiOne (autologous cells combination), Actifit (polymer meniscal implant)

• Determined and executed appropriate clinical and regulatory strategies for EU, US, and other markets.
• Set-up and executed first-in-man trial with an autologous cells combination (primary chondrocytes and mesenchymal stem cells in a co-polymer scaffold).
• Successfully managed product registration applications (INSTRUCT — approved in EU) and reimbursement dossier submissions (Actifit).
• Set-up and managed Post-Market Surveillance and Vigilance program.
• Oversaw the selection and management of CROs and vendors.
• Collaborated with the QA team to ensure the Quality Management System was compliant with European regulations and ISO standards.
• Supported due diligence and commercial/marketing activities.

Senior Clinical Project Manager at GENZYME FRANCE S.A.S. (2003-01 – 2009-08)

Products: Synvisc/Synvisc-One, Seprafilm, Carticel, MACI (autologous cells)

• Successfully led the Synvisc-One program (pilot / EU pivotal) from start to end leading to registration in EU and the US (Feb. 2009). Q1-2009 sales increased by 13% ($63M) in only 1 month.
• Launched the MACI program (first ATMP study at Genzyme).

Senior Clinical Research Associate at PPD FRANCE S.N.C. (1999-07 – 2001-04)

Clinical Team Manager at PPD FRANCE S.N.C. (2001-04 – 2003-01)

Clinical Research Associate at QUINTILES S.A. / INNOVEX FRANCE SARL (1996-02 – 1999-06)

BSc in Biochemistry – Faculté des Sciences de Rennes (1990)