PPlanet Pharma is currently recruiting for a Director, Clinical Project Management (General Outsourced Studies, Phases I–III). /ppbr/ppThe strongDirector of Clinical Project Management /strong will serve as the strategic and operational leader for a portfolio of strongglobal outsourced clinical trials (Phases I–III) /strong within a fast‑growing pharmaceutical organization. This role oversees end‑to‑end program delivery, with a strong emphasis on strongCRO governance /strong, strongstudy strategy /strong, strongrisk management /strong, and strongcross‑functional leadership /strong. 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. /ppbr/ppKey Responsibilities /pullistrongClinical Program Leadership /strong — Provide strategic oversight for global clinical programs across Phases I–III, ensuring alignment with corporate development goals and regulatory pathways. /lilistrongCRO Governance /strong — Lead the selection, negotiation, oversight, and performance management of CROs and key vendors; establish KPIs, quality metrics, escalation pathways, and governance structures. /lilistrongStudy Strategy Development /strong — Define operational strategies for each study, including country selection, enrollment modeling, risk mitigation, and budget planning. /lilistrongCross‑Functional Leadership /strong — Partner with Clinical Development, Regulatory, Biometrics, Pharmacovigilance, and Medical Affairs to ensure seamless program execution. /lilistrongOperational Excellence /strong — Drive continuous improvement initiatives, operational frameworks, and process optimization for outsourced clinical execution. /lilistrongRisk Issue Management /strong — Anticipate operational risks, lead cross‑functional mitigation planning, and ensure timely resolution of issues impacting quality, timelines, or cost. /lilistrongBudget Oversight /strong — Manage multimillion‑dollar study budgets, including forecasting, variance analysis, and vendor financial oversight. /lilistrongTeam Leadership /strong — Lead, mentor, and develop a team of Clinical Project Directors/Managers, fostering a culture of accountability, collaboration, and scientific rigor. /lilistrongRegulatory Quality Compliance /strong — Ensure all programs adhere to ICH‑GCP, global regulatory requirements, and internal quality standards. /li /ulpbr/ppRequired Qualifications /pullistrongClinical Operations Expertise /strong — Extensive experience in clinical project/program management within pharma or biotech, including leadership of global outsourced studies. /lilistrongCRO Management Experience /strong — Demonstrated success managing CROs across multiple regions and therapeutic areas. /lilistrongPhase I–III Experience /strong — Proven track record overseeing early‑ to late‑stage clinical trials with complex operational demands. /lilistrongLeadership Skills /strong — Experience leading high‑performing teams and influencing senior stakeholders. /lilistrongRegulatory Knowledge /strong — Deep understanding of global regulatory frameworks (FDA, EMA, MHRA, PMDA). /lilistrongStrategic Thinking /strong — Ability to translate development goals into operational strategies and execution plans. /lilistrongVendor Oversight /strong — Strong contract negotiation, KPI development, and vendor performance management capabilities. /liliBachelor’s degree required; advanced degree (MS, MPH, PharmD, PhD) preferred /li /ulpbr/ppPreferred Qualifications /pullistrongGlobal Trial Experience /strong — Experience with multi‑regional clinical trials (MRCTs) across North America, EU, and Asia‑Pacific. /lilistrongProcess Optimization /strong — Background in operational excellence, Lean, or Six Sigma methodologies. /lilistrongTherapeutic Area Expertise /strong — Experience in oncology, immunology, neurology, or rare disease preferred. /lilistrongPortfolio Management /strong — Ability to oversee multiple programs simultaneously with competing priorities. /li /ul