Delivery Director Clinical & Regulatory Affairs

• Solution Delivery Director - Clinical & Regulatory Affairs
  Location: Barcelona | Full-Time | Hybrid Possible

  Are you passionate about driving innovation at the intersection of clinical development, regulatory affairs, and technology? We are seeking a Solution Delivery Director to join our global IT organization and lead digital transformation in drug development.

  What You'll Do
  Act as a strategic IT leader and partner to Clinical and Regulatory teams. Own the IT product roadmap and oversee the delivery of technology solutions that align with compliance, user needs, and business goals. Drive collaboration with R&D, Quality, Data, and Infrastructure teams. Identify and implement emerging technologies to improve clinical operations and regulatory processes.

  What We're Looking For
  Extensive experience in clinical and regulatory drug development, with strong knowledge of GxP, FDA, EMA, and ICH. Proven leadership in IT roles within life sciences. Ability to manage full IT product lifecycles and translate complex requirements into impactful tech strategies. Strong communication and stakeholder engagement.

  Nice to Have
  Experience with Veeva, Medidata, Argus. Understanding of clinical trial data, biomarker data, and data flow from capture to analysis. Familiarity with SAS, R, Python. Knowledge of CSRs, real-time and retrospective analysis, and clinical decision support. Agile, SAFe, and global IT experience.

Montreal Associates is acting as an Employment Agency in relation to this vacancy.