VP Clinical Development & Translational Science

GRIFOLS, S.A.•NC-RTP, CA

3d•Hybrid

About The Position

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.

Requirements

MD, MD/PhD, PhD, PharmD, or equivalent advanced scientific/medical degree.
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.
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.

Nice To Haves

Experience across multiple therapeutic areas and development modalities strongly preferred.

Responsibilities

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, future‑ready capabilities that support pipeline growth, innovation, and accelerated development pathways.
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.
Works closely with external stakeholders and internal cross-functional groups to ensure the creation and execution of robust clinical strategies that effectively meet patient needs and business objectives. These groups include medical experts, advisory boards, patient advocacy groups, Clinical Operations, Pharmacovigilance, Biometry, Clinical Finance and Supplies, Medical Affairs, Legal, Commercial, Translational Medicine, and Regulatory.
Translates findings from research and non-clinical studies into potential clinical development opportunities. Collaborates with medical personnel and cross-functional teams to strategically evaluate these opportunities for commercial consideration. Provides medical personnel input on business cases for new products, indications, or technologies.
Accountable for establishing mechanistic understanding, defining dose and exposure-response relationships, and generating translational insight to enable informed development decisions from target validation through IND filing.
Reviews and guides clinical strategic plans with Grifols physicians and clinical scientists for clinical trial development relative to organizational goals. Ratifies strategic recommendations with senior management.
Reviews and approves medical assessment of trial results from tables and graph data presentations for global studies across therapeutic areas from a medical/scientific perspective.
Supervises departmental creation and content of all documents for regulatory submissions. Contributes to and/or reviews and approves key documents including Pre-Clinical & Clinical Study Reports, Briefing Books, Drug Safety Board Charters, Biological License Applications (ISS, ISE), White Papers, Investigator Brochures, Protocols, Amendments, and various Study plans.
Works with regulatory affairs to support pre-IND meetings with various regulatory agencies in various countries. Negotiates with regulators on pre-clinical and clinical programs and strategic intent, and communicates clinical feasibility and safety aspects of same.
Partners to troubleshoot study conduct issues and provide direction for pre-clinical or clinical responses to questions from investigators, site coordinators, health authorities, and institutional review boards.
Participates in pre-clinical and clinical program/data responses to FDA or other health authority queries.
Supervises and approves the development of all SOPs and working practices specific to Pharmacology and Translational Medicine, Clinical MDs/Scientists, and Medical Writing.
Manages the overall medical monitoring aspects of clinical trials. Provides consultation to Drug Safety and Regulatory Affairs and other stakeholders.
Aligns resourcing and department program prioritization in line with corporate goals.
Represents Grifols as a scientific speaker at stakeholder meetings, medical organizations, key customer meetings, industry associations, and advisory boards.
Reviews and makes recommendations on patent retention and Investigator Research Proposals to support other business units.
Attends meetings with regulatory authorities to support positioning of questions and data.
Ensures all key bioanalytic assay methods are developed and ready for measuring key analytes to support safety, efficacy, or pharmacokinetics in both pre-clinical and clinical studies, and ensures any vendors involved in the conduct of assays have validated methods.
Oversees the pharmacology and toxicology team members' programs to support development within both pre-clinical and clinical programs as applicable.