Vice President, Clinical Development

Vice President Clinical Development
Location: Dublin Ireland Barcelona Spain United States (RTP NC) Office-based Hybrid

Role Overview:

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.

Key Accountabilities
Strategic & Scientific Leadership
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.
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.
Clinical Pharmacology
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.
Medical Writing
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.
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 Pharmacologists and Medical Writers.
Establish best in class standards governance and processes across Clinical Development 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
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.
Collaborates with cross-functional teams to strategically evaluate new opportunities for commercial consideration. Provides clinical personnel input on business cases for new products indications or technologies.
Accountable for establishing mechanistic understanding defining dose and exposure-response relationships 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 clinical 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 clinical program/data responses to FDA or other health authority queries.
Supervises and approves the development of all SOPs and working practices specific to Clinical Development and Pharmacology 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..
Oversees the pharmacology team members programs to support development within both pre-clinical and clinical programs as applicable.

What does success in this role look like

Delivery of multiple high quality clinical programs progressing efficiently across development stages toward regulatory approval.
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.
Helps to develop team members for successful career development.

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active nonexpired Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; 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.

Location:NORTH AMERICA : USA : NC-RTP
EMEA : Ireland : Dublin:USNC0001 - RTP NC-Headquarters

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