Executive Director, Program and Study Management – Infectious Diseases and Vaccines

Jobtailor; New Jersey; On-site; USD 180,000 - 240,000; Full time

Job summary

Jobtailor in New Jersey seeks a seasoned Clinical Operations leader to translate strategic objectives into executable plans for a global clinical program. You will own operational planning, budgeting, and delivery across trials, collaborating with cross-functional teams and external partners.

The role requires extensive experience in clinical development, AI-enabled processes, and strong regulatory knowledge.

Qualifications

• Bachelor's degree required; concentration in a scientific-related discipline strongly preferred.
• 12+ years of relevant experience in clinical development programs in pharma, biotech, or CRO, or equivalent.
• Extensive experience planning and executing clinical trials.
• Ability to translate knowledge across Therapeutic Areas, Regional Operations, Data Management, Clinical Supplies, FSPs, and Vendors.
• Demonstrated ability to manage project scope, time, and cost.
• Proven ability to lead cross-functional strategic, process, and improvement initiatives.
• Expertise in designated therapeutic area and understanding of operational challenges.
• Experience implementing digital solutions, including AI, automation, and predictive analytics, to modernize clinical operations.
• Strong knowledge of GCP/ICH and global regulatory expectations.
• Proven history of developing talent and building robust talent pipelines.
• Executive presence and ability to influence across global R&D teams.
• Expertise in AI, Clinical Development, Clinical Trial Planning, Clinical Trials, Digital Leadership, Regulatory Requirements, and Vaccine Development.
• No visa sponsorship

Responsibilities

• Translate objectives into executable operational strategies for clinical programs and studies.
• Provide accountability for operational planning, execution, and delivery of the clinical program portfolio on time and within budget.
• Lead cross-functional trial delivery strategies and mitigate delivery risks.
• Oversee clinical trial management across all phases using KPIs, KPIs, predictive analytics, and AI-driven insights.
• Resolve complex operational issues and act as escalation point across functional leaders.
• Ensure compliance with GCP, ICH guidelines, and global regulatory requirements.
• Lead readiness for development reviews, operational reviews, inspections, and audits.
• Partner with Clinical leadership and represent GCTO operational needs and feasibility.
• Build and sustain strategic internal and external relationships.
• Provide leadership for a global program and study management team.
• Develop talent through onboarding, education, mentorship, performance management, succession planning, and career development.
• Champion inclusive, collaborative, innovative, high-performing teams.
• Modernize clinical trial operations through process simplification, AI, automation, and QoD approaches.
• Manage headcount and operating budgets for the assigned therapeutic area.
• Develop program-specific vendor strategies and oversee vendor delivery using KPIs and KQIs.
• Maintain an industry network and monitor industry trends, regulations, competitors, AI adoption, and operational frameworks.

Skills

Clinical Trial Management

Artificial Intelligence

Executive Leadership

Matrix Leadership

Cross-functional Collaboration

Strategic Leadership

Vendor Management

Education

Bachelor's degree

Tools

AI-Driven Insights

Automation

Digital Solutions

Job description

• Translate scientific and therapeutic-area objectives into executable operational strategies for clinical programs and studies
• Provide accountability for operational planning, execution, and delivery of the clinical program portfolio on time, within budget, and to high quality standards
• Lead cross-functional trial delivery strategies and assess and mitigate delivery risks
• Oversee clinical trial management across all phases using KPIs, KQIs, predictive analytics, and AI-driven insights
• Resolve complex operational issues and act as a key escalation point across functional leaders
• Ensure compliance with GCP, ICH guidelines, and applicable global regulatory requirements
• Lead readiness for development reviews, operational reviews, inspections, and audits
• Partner with Clinical leadership and represent GCTO operational needs and feasibility
• Build and sustain strategic internal and external relationships
• Provide visible leadership for a global program and study management team
• Develop talent through onboarding, education, mentorship, performance management, succession planning, and career development
• Champion inclusive, collaborative, innovative, and high-performing teams
• Modernize clinical trial operations through process simplification, AI, automation, and quality-by-design approaches
• Manage headcount and operating budgets for the assigned therapeutic area
• Develop program-specific vendor strategies and oversee vendor delivery using KPIs and KQIs
• Maintain an industry network and monitor industry trends, regulations, competitors, AI adoption, and operational frameworks

Requirements

• Bachelor's degree required; concentration in a scientific-related discipline strongly preferred
• 12+ years of relevant experience working on clinical development programs in pharma, biotech, or CRO, or equivalent combination of education and experience
• Extensive experience planning and executing clinical trials
• Ability to translate knowledge and expertise across Therapeutic Areas, Regional Operations, Data Management, Clinical Supplies, Functional Service Providers, and Vendors
• Demonstrated ability to manage project scope, time, and cost
• Business savvy and results oriented
• Proven ability to lead and contribute to cross-functional strategic, process, and improvement initiatives
• Expertise in the designated therapeutic area and understanding of its operational challenges
• Proven experience implementing digital solutions, including AI, automation, and predictive analytics, to modernize clinical operations
• Strong knowledge of GCP/ICH and global regulatory expectations
• Proven history of developing talent and building robust talent pipelines
• Exceptional executive presence and ability to influence without direct authority across complex global R&D teams
• Required expertise in Artificial Intelligence (AI), Clinical Development, Clinical Trial Planning, Clinical Trials, Digital Leadership, Executive Leadership, Global Team Collaboration, Good Clinical Practice (GCP), ICH GCP Guidelines, Infectious Disease, Key Performance Indicators (KPI), Matrix Leadership, Regulatory Requirements, Strategic Leadership, and Vaccine Development
• No visa sponsorship

Core Competencies

Demonstrates expertise in Clinical Development and Trial Management, with a strong focus on operational planning, execution, and compliance with GCP and ICH guidelines. Proven ability to lead cross-functional teams, implement digital solutions, and develop talent within a global clinical program environment.

Highest-signal resume keywords

• Clinical Trial Management
• Artificial Intelligence (AI)
• Good Clinical Practice (GCP)
• Regulatory Requirements
• Digital Leadership

ATS Optimization Keywords

Hard Skills

• Clinical Development
• Clinical Trial Planning
• Predictive Analytics
• Operational Planning
• Budget Management
• KPI Development
• Process Improvement
• Talent Development
• Vendor Management
• Matrix Leadership

Soft Skills

• Executive Presence
• Influencing Without Authority
• Collaboration
• Mentorship
• Strategic Leadership

Industry Keywords

• Pharma
• Biotech
• CRO
• Infectious Disease
• Vaccine Development
• Global Regulatory Compliance
• Therapeutic Areas

Tools & Technologies

• AI-Driven Insights
• Automation
• Digital Solutions