Director, Clinical Project Management (Global Outsourced Studies, Phases I–III) - bilbao
hace 4 días
Bilbao
Planet Pharma is currently recruiting for a Director, Clinical Project Management (Global Outsourced Studies, Phases I–III). 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., • Portfolio Management — Ability to oversee multiple programs simultaneously with competing priorities.
