Vice President, Clinical Development

Vice President, Clinical Development & Translational Science Location: United States (RTP, office‑based, hybrid) Reports To: Senior Vice President, Medical Development & Evidence Generation Role Overview 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. Key Accountabilities Strategic & Scientific Leadership 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. Clinical Development Excellence 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. Translational Science & Pharmacology 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. Regulatory & External Engagement 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. Organizational Leadership & Capability Building 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, future‑ready capabilities that support pipeline growth, innovation, and accelerated development pathways. Cross‑Functional Collaboration Partner closely with Clinical Operations, Regulatory Affairs, Biostatistics, Pharmacovigilance, Medical Affairs, Commercial, Health Economics, Legal, Finance, Global Program Teams, Project Management and external experts. Foster a collaborative, matrix‑based culture that promotes transparency, scientific rigor, and shared ownership of outcomes. Provide clinical insight into portfolio prioritization, resourcing decisions, and long‑range planning. Detailed Responsibilities Collaborate with cross‑functional teams to create and execute clinical strategies that meet patient needs and business objectives. Translate research findings into clinical development opportunities and evaluate them for commercial consideration. Establish mechanistic understanding, define dose and exposure‑response relationships, and generate translational insight for informed decisions from target validation through IND filing. Review and guide clinical strategic plans, advising on trial development relative to organizational goals. Approve medical assessment of trial results from tables and graphs for global studies across therapeutic areas. Supervise creation and content of regulatory submission documents, including study reports, briefing books, and investigator brochures. Work with regulatory affairs to support pre‑IND meetings and negotiate with regulators on program feasibility and safety. Address study conduct issues and provide direction for pre‑clinical or clinical responses to investigator queries. Participate in responses to FDA and other health authority queries. Supervise and approve development of SOPs and working practices for pharmacology, translational medicine, clinical scientists, and medical writing. Manage medical monitoring of clinical trials, consulting with Drug Safety and Regulatory Affairs. Align resourcing and program prioritization with corporate goals. Represent Grifols as a scientific speaker at stakeholder meetings and industry associations. Review and recommend on patent retention and investigator research proposals. Ensure bioanalytical assay methods are developed and ready for measuring key analytes. Oversee pharmacology and toxicology team programs to support development. What Does Success In This Role Look Like Delivery of multiple high‑quality clinical programs progressing efficiently toward regulatory approval. Strong translational framework that informs smarter, faster, and more confident development decisions. Highly engaged, high‑performing teams with clear succession and talent development pathways. Trusted partnerships with regulators and external stakeholders. Recognition of Grifols as a sponsor of scientific credibility, operational excellence, and patient‑focused innovation. Education MD, MD/PhD, PhD, PharmD, or equivalent advanced scientific/medical degree. Experience Typically 12+ years in pharmaceutical or biotechnology development in North America and/or Europe. Ideally with extensive experience in plasma therapeutics. Strong insight into clinical development strategy of non‑plasma therapies, such as recombinant proteins. Proven leadership in clinical development, with hands‑on experience across trial design, execution, interpretation, and regulatory submissions. Demonstrated experience working directly with global health authorities (FDA, EMA). Track record of leading and mentoring multidisciplinary, global teams in a matrix environment. Experience across multiple therapeutic areas and development modalities strongly preferred. Leadership & Personal Attributes Credible scientific leader with executive presence and strategic mindset. Collaborative, inclusive leader who inspires teams and encourages innovation. Comfortable navigating complexity, ambiguity, and change. Strong communicator with the ability to influence at senior and executive levels. Hands‑on, pragmatic, and outcomes‑driven, aligned with Grifols’ culture and values. Equal Opportunity Statement Grifols provides equal employment opportunities to applicants and employees without regard to race, color, sex, gender identity, sexual orientation, religious practices, national origin, pregnancy, childbirth, or related medical conditions, status as a protected veteran or spouse/family member of a protected veteran, or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. #J-18808-Ljbffr