Project Director I / II
Core
Plan and execute or oversee clinical trials for biotech and pharmaceutical companies, ensuring delivery on time, within budget, and in accordance with regulatory guidelines while managing a team of Project Managers and Associates.
Role type
Senior IC clinical trials project director
Builds
Clinical trial projects (FIH, HV, Phase 1 & 2) for emerging biotech and pharma companies
Domain
Clinical research / Biotechnology / Pharmaceuticals
Required skills
Clinical trial project management, team leadership, sponsor communication, study plan development, risk management, financial management, vendor management, regulatory compliance (ICH GCP), staff performance management
Preferred skills
Experience with emerging biotech companies, audit participation, serious adverse event reporting
Technologies
Clinical trial management systems, company SOPs, financial forecasting tools
Responsibilities
Provide guidance to Project Managers on project delivery; manage sponsor communication and expectations; develop study plans and documents; identify and report study-specific risks; manage project finances including invoicing and vendor payments; manage PM/PA resource assignments; monitor line reports' compliance and performance; manage staff recruitment, retention, and severance; manage contracted services and vendors; participate in audits; ensure Serious Adverse Events are reported.
Seniority
Senior, hands-on IC with line management