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Director, Clinical Project Management (Global Outsourced …, Santa María de Vigo

Director, Clinical Project Management (Global Outsourced …, Santa María de Vigo
Descripción
Planet Pharma is currently recruiting for a Director, Clinical Project Management (Global Outsourced Studies, Phases I–III).

No deje pasar esta oportunidad, inscríbase rápidamente si su experiencia y habilidades coinciden con lo que se indica en la siguiente descripción.

The

Director of Clinical Project Management

will serve as the strategic and operational leader for a portfolio of

global outsourced clinical trials (Phases I–III)

within a fast‑growing pharmaceutical organization. This role oversees end‑to‑end program delivery, with a strong emphasis on

CRO governance ,

study strategy ,

risk management , and

cross‑functional leadership . The Senior Director ensures that all programs meet quality, timeline, budget, and regulatory expectations while shaping the long‑term operational model for outsourced clinical development.

Key Responsibilities Clinical Program Leadership

— Provide strategic oversight for global clinical programs across Phases I–III, ensuring alignment with corporate development goals and regulatory pathways. CRO Governance

— Lead the selection, negotiation, oversight, and performance management of CROs and key vendors; establish KPIs, quality metrics, escalation pathways, and governance structures. Study Strategy Development

— Define operational strategies for each study, including country selection, enrollment modeling, risk mitigation, and budget planning. Cross‑Functional Leadership

— Partner with Clinical Development, Regulatory, Biometrics, Pharmacovigilance, and Medical Affairs to ensure seamless program execution. Operational Excellence

— Drive continuous improvement initiatives, operational frameworks, and process optimization for outsourced clinical execution. Risk&Issue Management

— Anticipate operational risks, lead cross‑functional mitigation planning, and ensure timely resolution of issues impacting quality, timelines, or cost. Budget Oversight

— Manage multimillion‑dollar study budgets, including forecasting, variance analysis, and vendor financial oversight. Team Leadership

— Lead, mentor, and develop a team of Clinical Project Directors/Managers, fostering a culture of accountability, collaboration, and scientific rigor. Regulatory&Quality Compliance

— Ensure all programs adhere to ICH‑GCP, global regulatory requirements, and internal quality standards.

Required Qualifications Clinical Operations Expertise

— Extensive experience in clinical project/program management within pharma or biotech, including leadership of global outsourced studies. CRO Management Experience

— Demonstrated success managing CROs across multiple regions and therapeutic areas. Phase I–III Experience

— Proven track record overseeing early‑ to late‑stage clinical trials with complex operational demands. Leadership Skills

— Experience leading high‑performing teams and influencing senior stakeholders. Regulatory Knowledge

— Deep understanding of global regulatory frameworks (FDA, EMA, MHRA, PMDA). Strategic Thinking

— Ability to translate development goals into operational strategies and execution plans. Vendor Oversight

— Strong contract negotiation, KPI development, and vendor performance management capabilities. Bachelor’s degree required; advanced degree (MS, MPH, PharmD, PhD) preferred

Preferred Qualifications Global Trial Experience

— Experience with multi‑regional clinical trials (MRCTs) across North America, EU, and Asia‑Pacific. Process Optimization

— Background in operational excellence, Lean, or Six Sigma methodologies. Therapeutic Area Expertise

— Experience in oncology, immunology, neurology, or rare disease preferred. xiphteb Portfolio Management

— Ability to oversee multiple programs simultaneously with competing priorities.

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