Director 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

Our exciting BioPharma with commercial products and a deep pipeline is looking for:

The Director, Clinical Operations will provide strategic and operational leadership for companies CNS clinical development portfolio. This individual will be responsible for the effective planning, execution, and oversight of global clinical trials, ensuring that studies are delivered with scientific rigor, operational excellence, and alignment with program objectives.

Reporting to the Executive Director of Clinical Operations, the Director will partner closely with Clinical Development, Regulatory Affairs, Biometrics, Medical Affairs, Quality, and external partners to drive the successful execution of clinical studies from early development through registration. This role will lead and develop a team of Clinical Operations Leaders, Clinical Trial Managers, and Clinical Trial Associates, while providing strategic direction across a complex, matrixed organization.

Key Responsibilities:

• Provide strategic and operational leadership for one or more neuroscience clinical development programs, ensuring successful delivery of clinical studies in accordance with the clinical development plan.
• Define and implement global clinical operations strategy, including study design considerations, timelines, budgets, resourcing, risk mitigation, and contingency planning.
• Direct clinical operations activities and decisions related to quality, cost, timelines, and overall study execution.
• Lead, coach, and develop a high-performing team of Clinical Operations Leaders, Clinical Trial Managers, and Clinical Trial Associates.
• Ensure appropriate oversight of clinical sites, CROs, and other external vendors, including documented oversight of outsourced activities.
• Build and manage strategic partnerships with CROs and other third-party vendors, ensuring accountability for quality, deliverables, timelines, and budget.
• Partner with Clinical Development, Biometrics, Regulatory, Medical Affairs, and Quality to ensure cross-functional alignment and timely resolution of operational issues.
• Oversee operational metrics, KPIs, study dashboards, and performance reporting; drive corrective actions and continuous improvement initiatives as needed.
• Ensure inspection readiness across clinical studies and partner with Quality to support inspections, audits, and corrective action planning.
• Represent Clinical Operations in governance forums, providing senior leadership with clear updates on program status, risks, milestones, and mitigation strategies.
• Foster innovation by identifying opportunities to improve clinical trial execution, leveraging industry best practices, technology, and process improvements.
• Build strong internal and external stakeholder relationships to support effective study execution and program strategy.

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, biotechnology, or clinical research industry.
• Demonstrated experience leading global clinical operations activities across Phase I–IV studies.
• Deep therapeutic expertise in neuroscience, CNS, psychiatry, neurology, or neurodegenerative disease is strongly 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, applicable global regulations, clinical development standards, and SOPs.
• Demonstrated ability to operate effectively in a fast-paced, matrixed environment, establish priorities, and deliver against aggressive timelines.
• Excellent verbal and written communication skills, with the ability to influence senior leaders and build effective cross-functional relationships.
• Strong leadership capabilities, including a passion for talent development, coaching, and building accountable, collaborative teams.
• Experience supporting regulatory inspections and quality/compliance initiatives preferred.Strong continuous improvement, problem-solving, and change management skills.