Project Director (Clinical Development)

TL;DR

Project Director (Clinical Development): Managing all aspects of phase I-IV patient clinical studies from start-up to close-out with an accent on project oversight, sponsor liaison, and financial management. Focus on delivering complex global studies, leading cross-functional teams, and influencing the organization's strategic direction through RFP inputs.

Location: United States (Boston, MA). Work format: Home Based or Hybrid.

Company

hirify.global is a full-service CRO delivering clinical studies from first-in-man through to Phase III for small and mid-size drug developers.

What you will do

• Lead all aspects of Phase I-IV patient clinical studies from start-up to close-out.
• Act as the primary point-of-contact and liaison for Sponsors to provide high-quality customer service.
• Provide oversight to Project Managers on large or multiple smaller studies.
• Manage project contractual deliverables, timelines, quality, scope, and finances.
• Support Commercial Development by contributing strategy and insights to RFPs and Bid Defence meetings.
• Line manage, mentor, and provide technical leadership to Project Managers.

Requirements

• Degree in life sciences or a related field.
• Experience managing full-service projects within a CRO or pharmaceutical industry.
• Proven track record of managing global Phase I-III patient studies.
• In-depth knowledge of ICH-GCP guidelines and clinical research regulatory requirements.
• Proficiency with eTMF and CTMS tools.
• Expertise in project finances, including revenue recognition and forecasting.

Nice to have

• Expertise with MS Project or similar Project Management software.
• Prior line management experience.
• Experience in Rare & Orphan Diseases or early-phase Oncology dose escalation.
• Experience with adaptive design studies or leading change processes.

Culture & Benefits

• Mission-driven environment focused on improving patients' lives.
• Flexible, innovative, and agile approach to clinical solutions.
• Professional growth through strategic influence on departmental direction.
• Opportunity to work within a structured, centralized leadership team.