Vice President, Clinical Development
Listed on 2026-09-12
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Business
Regulatory Compliance Specialist
Vice President, Clinical Development & Translational Science
Location:
United States (RTP, office‑based, hybrid)
Reports To:
Senior Vice President, Medical Development & Evidence Generation
Grifols is seeking a visionary and scientifically grounded Vice President of Clinical Development & Translational Science to lead and shape the strategy, execution, and evolution of our global clinical and translational 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 preclinical, translational, and clinical phases
, enabling informed, accelerated, and high‑quality decision‑making across the pipeline. 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 and translational 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/translational insight, mechanistic understanding, and dose/exposure‑response frameworks.
- 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 Translational Medicine, Pharmacology, and Preclinical Sciences, ensuring compelling biological rationale and continuity from bench to bedside.
- Drive development and validation of bioanalytical assays, biomarkers, and PK/PD strategies to support safety, efficacy, and dose selection.
- Ensure readiness of non‑clinical and translational packages to enable efficient IND filings and accelerated development where appropriate.
- 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, Translational Scientists, Pharmacologists, and Medical Writers.
- Establish best‑in‑class standards, governance, and processes across Clinical Development, Translational Science, and Medical Writing.
- Ensure excellence in GCP, GLP, ICH, and regulatory compliance, embedding quality and accountability across all activities.
- Build scalable,…
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