Associate Director/Director Clinical Operations in Newport

Contract Type: Freelance / Independent Consultant

Duration: 12-Month Full-Time Contract (40 hours/week)

Location: Remote (with occasional travel to investigator meetings, clinical sites, and company offices as required)

Therapeutic Area: Oncology | Radiopharmaceuticals | Molecular Imaging

Development Stage: First-in-Human (FIH) Clinical Programs

About the Opportunity:

We are seeking an experienced Associate Director / Director of Clinical Operations to lead operational execution of a First-in-Human (FIH) radiopharmaceutical oncology imaging program. This is a hands-on leadership role for a seasoned clinical operations professional with deep experience managing early-phase studies, complex imaging endpoints, and global or multicenter clinical trial execution.

The successful candidate will partner closely with Clinical Development, Medical Affairs, Regulatory Affairs, Biometrics, Quality, and external vendors to ensure clinical studies are delivered on time, within budget, and in compliance with GCP, ICH guidelines, and applicable regulations. This position is ideal for a clinical operations leader who thrives in a fast-paced biotech environment and has prior experience supporting novel oncology imaging agents, radiopharmaceuticals, PET tracers, or nuclear medicine clinical programs.

Key Responsibilities:

• Clinical Trial Leadership
  • Lead operational planning and execution of Phase 0/I First-in-Human oncology imaging studies.
  • Develop and maintain comprehensive clinical trial timelines, risk management plans, and study execution strategies.
  • Drive study start-up activities including site identification, feasibility, site selection, activation, and enrollment planning.
  • Oversee study conduct from initiation through database lock and clinical study report support.
• Vendor & CRO Management
  • Serve as primary operational lead for CROs and specialty vendors.
  • Manage central imaging vendors, radiopharmacies, dosimetry providers, laboratories, and technology platforms.
  • Establish vendor performance metrics and ensure adherence to contractual obligations.
  • Lead governance meetings and issue escalation processes.
• Site Management & Oversight
  • Provide operational oversight of investigative sites and study teams.
  • Support site training, enrollment acceleration initiatives, and protocol compliance.
  • Monitor study performance metrics and proactively address recruitment and retention challenges.
  • Ensure appropriate handling, administration, and tracking of investigational radiopharmaceutical products.
• Cross-Functional Collaboration
  • Partner with Clinical Development and Medical Monitoring teams on protocol execution strategies.
  • Collaborate with Regulatory Affairs regarding submissions, amendments, and health authority interactions.
  • Work closely with Data Management, Biostatistics, and Medical Writing to support study deliverables.
  • Contribute to Clinical Trial Team leadership and governance meetings.
• Risk Management & Quality
  • Identify operational risks and implement mitigation strategies.
  • Ensure inspection readiness across all study activities.
  • Support audit preparation and management of CAPAs where required.
  • Maintain compliance with ICH-GCP, FDA, EMA, and applicable regional regulations.
• Budget & Resource Management
  • Develop and manage clinical trial budgets and forecasts.
  • Track study expenditures and vendor costs.
  • Support contract negotiations and scope management activities.
  • Ensure efficient utilization of clinical resources.

Required Qualifications:

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related discipline.
• 8+ years Associate Director level/Director level of clinical operations experience within biotech, pharmaceutical, CRO, or radiopharmaceutical organizations.
• Demonstrated experience leading Phase I and First-in-Human clinical trials.
• Strong understanding of oncology drug development and clinical trial operations.
• Experience managing CROs and multiple external vendors.
• Proven ability to independently drive study execution in resource-limited biotech environments.
• Strong knowledge of ICH-GCP, FDA, EMA, and international clinical research regulations.
• Excellent stakeholder management, communication, and project leadership skills.