Executive Director, Clinical Operations Program Management (Vaccines and Immune Therapies)

Job Title: Executive Director, Clinical Operations Program Management (V&I)

Possible Locations: Gaithersburg, MD or Boston, MA | BioPharma R&D

Job Title: Executive Director, Clinical Operations Program Management (Vaccines & Immune Therapies)

Introduction to role

Are you ready to lead and innovate in the world of clinical operations? As the Executive Director of Clinical Operations Program Management (COPM) for Vaccines & Immune Therapies, you will be at the forefront of driving strategic initiatives and shaping the future of clinical operations. Reporting to the VP of Clinical Operations, you will manage a team of Program Management Senior Directors and play a pivotal role in delivering our clinical operations portfolio. Your leadership will influence best practices, foster collaboration, and drive innovation across the enterprise.

Accountabilities

• Lead functional leadership, recruitment, capability building, and performance management for V&I Clinical Operations Program Management staff.
• Provide strategic guidance for new and existing programs, integrating clinical trial design, regulatory environments, and market access considerations.
• Ensure clinical trials are delivered on time, within budget, and to high-quality standards by leveraging data insights.
• Represent Clinical Operations on Steering Committees and cross-functional initiatives.
• Drive clarity and consistency across strategic processes and establish best practices for clinical trial delivery.
• Conduct rigorous analysis of data to identify trends and opportunities for optimization.
• Develop forward-thinking strategies for clinical operations program management, utilizing AI and advanced analytics.
• Mentor and support people development within Clinical Operations and other functions.
• Champion new ways of working and drive the implementation of innovative initiatives.

Essential Skills/Experience

• Bachelor of Science/Master of Science degree in related discipline, or equivalent work experience. Advanced degree is preferred
• 10 years+ of experience in global drug development leadership or equivalent leadership experience demonstrated in a variety of roles across early and late phase development.
• Understanding and communication of complex study design, TPPs, CDP’s, combination approaches, competition, pricing, prioritization, and decision making considerations
• Comfortable with AI and utilizing AI to support ethical and accurate analyses of data
• Experience in leading and mentoring a diverse, high-performing team.
• Excellent communication and presentation skills, with the ability to engage and inspire collaborators at all levels, both internally and externally.
• Clear and organized thinking with ability to simplify and prioritize complex problems
• Strong understanding of financial evaluation of an asset or brand
• Organizational awareness and experience of clinical operations business planning
• Ability to establish and maintain credibility with senior audiences
• Proven ability to develop programs to meet business goals and to assess business risk versus potential value; ability to understand global business requirements
• Significant experience of program management and use of project management techniques in complex projects, including resourcing, financial management and business case development
• Proven ability to develop successful collaborations with internal stakeholders and external partners
• Strong strategic influencing skills; ability to influence broadly within and outside the organisation
• Proven teamwork and ability to work collaboratively across a wide range of disciplines
• Track record of planning, prioritisation and delivery success
• Willingness to travel both domestic and international

Desirable Skills/Experience

• Demonstrated ability to drive process improvement and/or functional work
• Experience of implementing changes in ways of working that focus on increasing efficiency
• Regulatory submission experience
• Previous success of working in Japan and China to ensure delivery of global programmes to meet business needs
• Proven experience in leading teams through change
• Experience of and insight into the Clinical environment to be able to drive major improvement programs

Impact: This role sits on the V&I Clinical Operations Leadership Team and the BioPharmaceuticals Clinical Operations Extended Leaders Community, shaping strategy and execution across a high‑visibility portfolio that advances patient outcomes globally.

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