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Associate Director, Clinical Operations

10 hours, 55 minutes ago
United States
Full-time
Executive
Operations Manager
Project and Program Management
Apply Now
Telix Pharmaceuticals

Telix Pharmaceuticals

Telix Pharmaceuticals is a global biopharmaceutical firm dedicated to the development and commercialization of diagnostic and therapeutic products that utilize targeted radiation, aiming to enhance treatment decisions and provide personalized therapies...

Pharmaceuticals
201-500
Founded 2015
View All Jobs 31

Description

  • Lead end-to-end operational planning, execution, reporting, and closeout of clinical trials across assigned programs.
  • Manage multidisciplinary internal teams, CROs, vendors, investigator sites, and development partners to deliver studies on schedule, budget, and quality targets.
  • Develop study plans, timelines, budgets, forecasts, KPIs, and budget-versus-actual variance analyses.
  • Lead global patient recruitment planning and communicate with principal investigators.
  • Oversee CRO and vendor sourcing, RFPs, selection, contracts, performance, and day-to-day operations.
  • Develop proactive risk, contingency, and change-control plans for clinical studies.
  • Ensure compliance with study plans, GCP, ICH guidelines, regulatory requirements, SOPs, and inspection-readiness standards.
  • Oversee Trial Master File setup, maintenance, closeout, completeness, and audit readiness; support audits and inspections.
  • Partner with cross-functional teams on protocol and informed-consent feasibility, CRF design, user acceptance testing, safety processes, and development strategy.
  • Line-manage, mentor, and develop clinical operations staff and support clinical project managers.

Requirements

  • Bachelor’s degree in health science or a related field; advanced scientific degree preferred.
  • 6+ years of clinical research experience in biotechnology or pharmaceuticals, including Phase 1–4 multinational studies.
  • 4+ years of clinical project management experience with global clinical studies.
  • Knowledge of ICH guidelines, GCP, and global clinical-trial regulatory requirements.
  • Understanding of clinical development processes and cross-functional coordination across internal teams and third parties.
  • Experience in oncology, nuclear medicine, and/or radiopharmaceutical clinical trials preferred.
  • Experience leading teams, managing direct reports, and coaching others preferred.
  • Advanced proficiency with Veeva Vault, EDC systems such as Medidata Rave and Viedoc, and Microsoft Office Suite.
  • Strong organizational, analytical, problem-solving, communication, presentation, and stakeholder-management skills.
  • Ability to manage competing priorities, adapt to change, collaborate inclusively, and act with integrity.

Benefits

  • Competitive salary.
  • Annual performance-based bonus.
  • Equity-based incentive program.
  • Generous vacation time and paid wellness days.
  • Hybrid and remote work opportunities.
  • Learning and development support.

Interested in this position?

Apply directly on the company website

Apply Now

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