Steven De Hertefelt

Senior Director @ PSI | Global Pivotal Studies in IBD/GI, Oncology, Radiopharm, HemOnc, Supportive Care, IPF, Hemophilia, MS, AD/PD, anti-infectives, anti-fungals. Long-standing PCMG Assembly Steering Committee member.

Meise, Flemish Region, Belgium

About

I have a diverse professional background in B2B Industry, Medical Devices and Clinical Trials. For the last 15 years i worked exclusively in the Clinical Research environment, both for 3rd party vendors (Cardiac Safety, Spirometry, eCOA vendor, Imaging Core Lab and eClinical Vendor) and full service CROs (midsize and large organizations, both early phase and late phase, in different indications but with a specialty focus on Oncology). I am recognized as a leader and expert in CRO Industry and also a long standing member of the PCMG community, having contributed for 10+ years to the Assembly’s Steering Committee. In 2024 i stepped up to Sub-team Vice Lead of the 2025 Assembly. Multi-lingual (8 languages) European based Executive Business Development Director full service CRO. Strategic thinker and team-player. Specialty: Small to midsize Oncology biotech/pharma, Radiopharmaceuticals, Oncology, CAGT and Medical Devices, Biotech all Therapeutic Indications. Global Experience: EU+US+APAC. languages: Dutch - Spanish - English - French - Portuguese: fluent German - Italian: good (spoken) Catalan: notions

Experience

  • Senior Director Business Development at PSI CRO AG
    Aug 2023 - Present · 2 yrs 11 mos

    specialisation: Global Late Phase (II and III) studies in IBD/GI (including UC/CD/FSCD/celiac), Oncology, Hemato-Oncology, radiopharmaceuticals/theranostics, Anti-fungals, IPF and other respiratory (Asthma/COPD), Neurology (MS, AD/PD and spasticity), supportive care trials, haemophilia and other hematology disorders, gene therapy, biosimilars and antibiotics.

  • PCMG Assembly Steering Committee Member at PCMG Clinical Outsourcing Community
    Sep 2013 - Present · 12 yrs 10 mos

    https://pcmgassembly.org/

  • Precision For Medicine (Brussels Region, Belgium · Remote)
    • Executive Director Clinical Business Solutions, Oncology, Europe
      Jun 2022 - Jun 2023 · 1 yr 1 mo

      My focus and area of expertise is Oncology, Immune-Oncology and Cell&Gene Therapy; both biotech and midsize pharma

    • Senior Director Clinical Business Solutions, Oncology, Europe
      Mar 2020 - Jun 2022 · 2 yrs 4 mos

      My focus and area of expertise is Oncology, Immune-Oncology and Cell&Gene Therapy

  • Director Business Development R&D SOLUTIONS, IQVIA BIOTECH at IQVIA
    Jul 2018 - Feb 2020 · 1 yr 8 mos

    Business Development R&D Solutions Belgium and The Netherlands NOVELLA Clinical is now IQVIA BIotech. Find out more: https://www.iqviabiotech.com

  • Director, Business Development Europe, Oncology and MD&D at Novella Clinical
    Nov 2014 - Jul 2018 · 3 yrs 9 mos

    Since Feb 2019, Novella Clinical is now IQVIA BIOTECH. Find out more: https://www.iqviabiotech.com Novella Clinical, a Quintiles Company, is a specialty CRO focused solely on the unique needs of small to mid-sized oncology companies and medical device and diagnostic companies. We intentionally built the flexible business model, global capabilities and therapeutically aligned staff who thoroughly understand the specific requirements of oncology and medical device trials.