Global Director, Neuro Clinical Operations

Green Key Resources; Massachusetts; On-site; USD 180,000 - 280,000; Full time

Job summary

Green Key Resources’ BioPharma division seeks a Director, Clinical Operations to lead global neuroscience programs from development through registration. You will shape global operations strategy, oversee study design considerations, timelines, budgets, and vendor management, and report to the Executive Director.

You will build and lead a high-performing team, establish cross-functional alignment with Regulatory, Biometrics, Medical Affairs, and Quality, and drive inspection readiness and

Qualifications

• MS degree with a minimum of 10 years of experience, or BS degree with a minimum of 15 years of experience in the pharmaceutical/biotech/clinical research industry.
• Experience leading global clinical operations activities across Phase I–IV studies.
• Deep therapeutic experience in neuroscience, CNS, psychiatry, neurology, or neurodegenerative disease preferred.
• Proven experience managing and developing clinical operations teams, including Clinical Trial Managers and Clinical Operations Leaders.
• Strong background in clinical trial strategy, operational planning, budget management, resource forecasting, and vendor/CRO oversight.
• Experience with KPI management, contract negotiations, and clinical business financial models.
• Advanced knowledge of ICH/GCP, global regulations, clinical development standards, and SOPs.
• Demonstrated ability to operate effectively in a fast-paced, matrixed environment and meet aggressive timelines.
• Excellent verbal and written communication skills with the ability to influence senior leaders and cross-functional teams.
• Strong leadership, talent development, coaching, and building accountable, collaborative teams.

Responsibilities

• Provide strategic and operational leadership for one or more neuroscience clinical development programs, ensuring timely delivery of studies.
• Define and implement global clinical operations strategy, including study design, timelines, budgets, resourcing, risk mitigation, and contingency planning.
• Direct clinical operations activities related to quality, cost, timelines, and study execution.
• Lead, coach, and develop a high-performing team of Clinical Operations Leaders, Clinical Trial Managers, and Clinical Trial Associates.
• Ensure oversight of clinical sites, CROs, and other external vendors, including documented oversight of outsourced activities.
• Build and manage strategic partnerships with CROs and third-party vendors, ensuring quality and on-time deliverables.
• Partner with Clinical Development, Biometrics, Regulatory, Medical Affairs, and Quality for cross-functional alignment.
• Oversee operational metrics, KPIs, study dashboards, and performance reporting; drive corrective actions.
• Ensure inspection readiness and support audits and corrective action planning with Quality.
• Represent Clinical Operations in governance forums with senior leadership on status, risks, milestones, and mitigation.
• Foster innovation by adopting industry best practices, technology, and process improvements.
• Build strong internal and external stakeholder relationships to support study execution and program strategy.

Job description

Green Key Resources’ BioPharma division seeks a Director, Clinical Operations to lead global neuroscience programs from development through registration. You will shape global operations strategy, oversee study design considerations, timelines, budgets, and vendor management, and report to the Executive Director.

You will build and lead a high-performing team, establish cross-functional alignment with Regulatory, Biometrics, Medical Affairs, and Quality, and drive inspection readiness and