Vice President, Clinical Development

Vice President, Clinical Development

Location:

Dublin, Ireland | Barcelona, Spain | United States (RTP, NC) | Office-based, Hybrid

Grifols is seeking a visionary and scientifically grounded Vice President of Clinical Development to lead and shape the strategy, execution, and evolution of our global clinical development organization. This is a high-impact, enterprise leadership role at the heart of Grifols’ innovation engine. The successful candidate will define and deliver integrated development strategies spanning all clinical phases, enabling informed, accelerated, and high-quality decision making across the pipeline.

Key functional areas reporting to this role are Clinical Development, Clinical Pharmacology, and Medical Writing. With responsibility across a diverse therapeutic portfolio and modalities—including plasma-derived products and recombinant proteins—this role offers a rare opportunity to build future-ready development capabilities, influence portfolio strategy, and lead teams that translate deep biological insight into medicines that meaningfully improve patients’ lives.

• Define, own, and execute end-to-end clinical development strategies across all development phases.
• Provide senior scientific and clinical leadership to development teams and executive management, serving as a trusted advisor on program risk, opportunity, and strategic trade offs.
• Shape portfolio strategy through rigorous clinical insight, defining TPPS, and defining PTRSs.
• Lead due diligence for new indications, assets, and patient solutions, contributing clinical and translational expertise to business development decisions.

• Oversee the design and execution of global clinical development plans, protocols, and trials, including first in human studies and large, randomized, multi regional trials.
• Ensure clinical programs are scientifically sound, operationally executable, and aligned with regulatory and patient expectations.
• Interpret and integrate clinical data to guide development decisions and support global regulatory submissions (INDs, BLAs/NDAs).
• Lead clinical advisory boards, investigator meetings, and external scientific engagements.

• Provide strategic oversight of Clinical Pharmacology strategies to support development programs ensuring compelling biological rationale.
• Drive development and validation of PK/PD strategies to support safety, efficacy, and dose selection.
• Ensure readiness of clinical pharmacology packages to enable efficient IND filings and accelerated development where appropriate.

• Author and deliver high-quality clinical regulatory documents:
  Lead the planning, writing, and review of key documents including clinical study reports (CSRs), protocols, investigator brochures, briefing packages, and regulatory submissions, ensuring clarity, scientific rigor, and compliance with ICH/GCP and regulatory guidelines.
• Drive cross-functional document development and consistency:
  Partner with Clinical Development, Biostatistics, Regulatory Affairs, Pharmacovigilance, and Translational teams to integrate diverse inputs into cohesive, accurate, and strategically aligned documents that support global development objectives.
• Ensure regulatory readiness and quality standards:
  Manage timelines, document quality control, and review cycles; ensure consistency of messaging across programs; and incorporate x-functional team feedback, and supporting responses to health authority queries.

• Serve as a senior clinical representative with FDA, EMA, and global health authorities, supporting pre IND, scientific advice, BLAs and regulatory negotiations.
• Approve and contribute to key regulatory and scientific documents, including briefing books, study reports, investigator brochures, and white papers.
• Represent Grifols externally as a scientific thought leader in industry forums, advisory boards, and key stakeholder meetings.

• Lead and develop a globally distributed team of Clinical Physicians, Clinical Scientists,…