Executive/Senior Director, Clinical Operations

Role Summary

The Executive/Senior Director of Clinical Operations provides strategic and operational leadership for the planning, execution, and delivery of clinical studies across multiple development programs, ensuring that study strategies, timelines, budgets, and operational plans align with overall portfolio objectives and corporate priorities. This role oversees vendor identification, selection, contracting, and performance management; leads the review and approval of study-related documents and operational materials; and proactively identifies risks while developing robust mitigation and contingency plans to ensure high-quality and efficient trial execution. The Executive/Senior Director leads the Clinical Operations team in building strong, collaborative partnerships with cross-functional colleagues in Clinical Development, Biometrics (with particular emphasis on Data Management), Quality Assurance, CMC, and Medical Affairs, promoting shared accountability, transparent communication, and integrated operational planning. Additionally, this leader plays a critical role in shaping and maturing the Clinical Operations organization by developing scalable processes, governance structures, and operational infrastructure that support a growing and evolving clinical portfolio. They are also responsible for cultivating a high-performing team through mentorship, coaching, and professional development, fostering an environment that values continuous learning, proactive problem-solving, and operational excellence, and ensuring the function is equipped with the capabilities and leadership depth needed to meet both current and future organizational needs.

Location: Corporate Office/Remote (Travel 15%)

Responsibilities

• Manage in-house clinical operations.
• Identify and evaluate potential clinical partners which may include investigators and vendors necessary to execute the clinical program.
• Provide strategic input into the development of clinical trial protocols to ensure clinical designs are implementable to efficiently achieve the objectives.
• Provide strategic input into the collection and analysis of clinical trial data.
• Establish timelines and budget for delivery of clinical development program.
• Oversee, coach and develop staff responsible for delivery of clinical trials.
• Lead the development of contingency/risk management plans for projects with a focus on ensuring studies delivery according to principles of GCP.
• Lead development and review of Clinical Development processes, systems and initiatives.

Qualifications

• Excellent knowledge of Good Clinical Practice (GCP), including global regulatory standards, ethical requirements for the protection of human subjects, and oversight of GCP-compliant clinical trial conduct and inspection readiness.
• Demonstrated experience supporting and contributing to NDA filings and major global regulatory submissions.
• Minimum of 10 years of progressive Clinical Operations experience, including senior leadership roles with portfolio-level responsibility.
• Proven ability to provide strategic leadership across a clinical development portfolio, balancing timelines, resources, risk, and cost across multiple programs and indications.
• Extensive experience leading and overseeing clinical trials across multiple phases, including Phase II/III studies and regulatory post-marketing commitments, with accountability for delivery at both program and portfolio levels.
• Demonstrated success in building, mentoring, and leading high-performing Clinical Operations teams, fostering accountability, collaboration, and professional development.
• Strong expertise in planning, forecasting, and portfolio governance, with the ability to anticipate operational risks and proactively drive mitigation strategies across programs.
• Extensive experience working in multicultural and multinational clinical development environments, including leadership of global vendors and cross-functional teams.
• Excellent written and verbal communication skills, with a proven ability to influence senior leadership and align internal and external stakeholders around portfolio priorities.
• Master’s or PhD in a scientific discipline strongly preferred

Education

• Master’s or PhD in a scientific discipline strongly preferred