Job Description
A well-regarded Clinical Research Facility is seeking a driven and experienced Phase I Unit Director / Site Director to lead operations at one of its growing sites. This is a pivotal opportunity to launch and lead a newly established Phase I unit, driving clinical performance while ensuring the delivery of high-quality early-phase trials in a highly reputable research environment.
This role requires a hands-on leader with recent Phase I experience who is comfortable being closely involved in day-to-day operations, unit setup, and team leadership.
Key Responsibilities:
- Provide overall leadership and oversight for the Phase I unit, ensuring operational excellence across clinical, financial, and administrative functions.
- Play a key role in the final stages of Phase I unit build-out, including workflow design, operational readiness, and process implementation.
- Establish and optimise Phase I specific operational procedures, ensuring readiness for first-in-human and early-phase studies.
- Manage team workload, scheduling, and resource planning to support Phase I study demands.
- Oversee and optimise subject recruitment, screening, and retention for early-phase trials.
- Ensure full compliance with ICH GCP, FDA regulations, and company SOPs, with particular attention to Phase I safety, dosing, and monitoring requirements.
- Act as a key point of contact for sponsors, CROs, and internal stakeholders for Phase I studies.
- Manage site financials including budgeting, reporting, and invoicing, with accountability for Phase I unit performance and growth.
- Support longer-term growth strategies, including expansion of Phase I capabilities and integration with existing research programs.
Qualifications and Skills:
- Bachelor’s degree required; advanced degree preferred.
- 10+ years of experience in clinical research, with at least 5 years in site or unit leadership.
- Recent, hands-on Phase I clinical research experience is essential, including an understanding of early-phase operational nuances.
- Prior experience setting up, scaling, or leading a Phase I unit is highly preferred.
- Strong leadership presence with the ability to balance strategic oversight and hands-on involvement.
- Excellent communication and stakeholder management skills.
- Candidates who value stability, team development, and long-term commitment will be a strong cultural fit.
Role Details:
- Competitive compensation package with strong benefits.
- Annual bonus potential.
- Relocation support available.
Be part of a forward-thinking organization dedicated to advancing healthcare breakthroughs through clinical research. If you are a Phase I leader looking to take ownership of a unit build and lead within a highly established and respected research environment, we would welcome your application.