Project Director I / II
Core
Planning and executing or overseeing clinical trials (FIH, HV, Phase 1 & 2) for biotech and pharmaceutical companies, ensuring compliance with protocols and regulations while managing a team of Project Managers and Project Associates.
Role type
Senior IC clinical trials Project Director
Builds
Clinical trial projects for emerging biotech companies
Domain
Clinical research / Biotech / Pharma
Required skills
Clinical trial project management, team leadership, stakeholder communication, risk management, financial management, regulatory compliance (ICH GCP), vendor management, audit response, adverse event reporting
Preferred skills
Experience with emerging biotech companies, strategic partnership development
Technologies
Clinical trial management systems, company SOPs
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 financials including forecasting and invoicing; 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