Planet Pharma is currently recruiting for a Director, Clinical Project Management (Global Outsourced Studies, Phases I–III).
Director of Clinical Project Management
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 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
* Provide strategic oversight for global clinical programs across Phases I–III, ensuring alignment with corporate development goals and regulatory pathways.
* Lead the selection, negotiation, oversight, and performance management of CROs and key vendors;
establish KPIs, qualitymetrics, escalation pathways, and governance structures.
* Define operational strategies for each study, including country selection, enrollment modeling, risk mitigation, and budget planning.
* Partner with Clinical Development, Regulatory, Biometrics, Pharmacovigilance, and Medical Affairs to ensure seamless program execution.
* Drive continuous improvement initiatives, operational frameworks, and process optimization for outsourced clinical execution.
* Anticipate operational risks, lead cross‑functional mitigation planning, and ensure timely resolution of issues impacting quality, timelines, or cost.
* Manage multimillion‑dollar study budgets, including forecasting, variance analysis, and vendor financial oversight.
* Lead, mentor, and develop a team of Clinical Project Directors/Managers, fostering a culture of accountability, collaboration, and scientific rigor.
* Ensure all programs adhere to ICH‑GCP, global regulatory requirements, and internal quality standards.
Required Qualifications
* Extensive experience in clinical project/program management within pharma or biotech, including leadership of global outsourced studies.
* Demonstrated success managing CROs across multiple regions and therapeutic areas.
* Proven track record overseeing early‑ to late‑stage clinical trials with complex operational demands.
* Experience leading high‑performing teams and influencing senior stakeholders.
* Deep understanding of integral regulatory frameworks (FDA, EMA, MHRA, PMDA).
* Ability to translate development goals into operational strategies and execution plans.
* Strong contract negotiation, KPI development, and vendor performance management capabilities.
* Bachelor’s degree required;
advanced degree (MS, MPH, PharmD, PhD) preferred.
Preferred Qualifications
* Experience with multi‑regional clinical trials (MRCTs) across North America, EU, and‑Pacific.
* Background in operational excellence, Lean, or Six Sigma methodologies.
* Experience in oncology, immunology, neurology, or rare disease preferred.
* Ability to oversee multiple programs simultaneously with competing priorities.
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