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, qualitymetrics, 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.