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.