Executive Director, Program and Study Management, Ophthalmology

Global Clinical Trial Operations (GCTO) is a global organization with over 10,000 people operating in 50 countries. The Program and Study Management organization is a sub-functional unit within GCTO, divided into therapeutic clusters, with approximately 500 people, and is accountable for all operational, technical, and scientific aspects of HQ-sponsored clinical trials, including a grant budget of more than $1B.

Responsibilities

• Strategic Leadership and Alignment
  • Translate scientific and therapeutic area (TA) objectives into robust, executable operational strategies for all clinical programs and studies.
  • Guide GCTO teams to understand the competitive landscape, the scientific rationale for development programs, and the long-term vision for assets.
• End-to-End Program and Study Delivery [Execution Excellence]
  • Full accountability for the operational planning, execution, and delivery of the clinical program portfolio on time, within budget, and with the highest standards of quality.
  • Ensure proactive cross-functional collaborations to develop robust trial delivery strategies (e.g., via Product Development Teams, Clinical Sub Teams, deep dives, immersion meetings).
  • Assess trial delivery risk monthly and initiate cross-functional forums to address issues.
  • Provide oversight for all phases of clinical trial management, ensuring performance against key indicators (KPIs) and key quality indicators (KQIs) across domains such as:
    • Product and Major Milestone delivery
    • Cycle Times: Including Time to First Patient In (FPI), Time to Site Ready 80%, Site Activation Time, and Database Lock Time
    • Enrollment, Retention, and Data Quality
    • On-time, within-budget delivery of Last Patient In (LPI)
    • Quality: Including Protocol Deviation Rate, Data Entry/Query metrics, Issue Management, eTMF compliance, CV/Org Charts, Training
  • Drive alignment of Critical-to-Quality (CtQ) factors at the program level.
  • Leverage predictive analytics and AI-driven insights to proactively identify, monitor, and mitigate operational risks.
  • Act as key escalation point for resolving complex operational issues affecting program and study delivery.
  • Ensure all activities are conducted in compliance with Good Clinical Practice (GCP), ICH guidelines, and all applicable global regulatory requirements.
  • Ensure readiness and leadership for GCD late-stage development reviews, GCTO Ops review, inspections, and audits.
• Therapeutic Area (TA) Expertise and Collaboration
  • Serve as the key operational partner to Clinical leadership, ensuring GCTO capabilities and strategies are fully integrated to meet the needs of the development pipeline.
  • Champion and represent GCTO needs and operational feasibility.
  • Proactively build and sustain strategic internal and external relationships to accelerate PSM priorities.
  • Ensure a deep understanding of the science and strategic context of the assigned TAs to inform and challenge operational strategies effectively.
• People Leadership and Development
  • Build organizational talent and create a work environment where teams and individuals can reach their full potential.
  • Provide visible, hands-on leadership for a global team of program and study management professionals, fostering a culture of accountability, collaboration, operational excellence, quality, and continuous improvement.
  • Empower teams to identify bottlenecks and allocate resources effectively.
  • Build and develop a high-performing team through robust onboarding, continuous education, structured mentorship, and effective resource management.
  • Set clear performance expectations, hold leaders accountable for outcomes and behaviors, and champion the modernization of operations.
  • Recruit, resource plan, and build capabilities, including talent reviews, succession planning, and targeted development actions.
  • Sponsor career development pathways that attract, retain, and grow talent.
  • Champion a positive and inclusive work environment that encourages cross-functional teamwork, innovation, and professional growth.
  • Provide guidance to line managers on building and leading high-performing teams and managing resources effectively.
• Operational Excellence and Modernization
  • Champion the modernization of clinical trial operations by identifying and implementing innovative processes, simplification, and AI- and automation-enabled solutions.
  • Ensure PSM processes are state-of-the-art, agile, and built with quality by design.
  • Ensure awareness of enterprise initiatives, drive adoption, and champion the "why."
• Resourcing, Vendor Management, and Financial Stewardship
  • Accountable for the effective planning and management of all resources (headcount and operating budget) for the assigned TA.
  • Drive program-specific vendor strategies, building collaborative partnerships tailored to the scientific and operational complexities of the portfolio.
  • Provide rigorous oversight of vendor delivery and drive mutual accountability through continuous monitoring of robust KPIs and KQIs.
• External Facing Leadership and Competitiveness
  • Build and maintain a strong industry network.
  • Stay abreast of the external landscape, including industry trends, new regulations, and competitor activities.
  • Leverage knowledge of industry-wide AI adoption and operational frameworks to inform strategy and ensure the company's capabilities are best-in-class.

Requirements

• Bachelor’s degree required with a concentration in a scientific-related discipline strongly preferred.
• Advanced scientific degree (e.g., MS, PharmD, Ph.D.) or a combination of equivalent experience and training preferred.
• 12+ years of relevant experience working on clinical development programs (pharma/biotech/CRO) or equivalent combination of education and experience required.
• Extensive experience in the planning and execution of clinical trials with demonstrated ability to translate knowledge and expertise across organizational levels.
• Demonstrated ability to effectively manage scope, time, and cost of assigned projects; business-savvy and results-oriented.
• Proven ability to lead and actively contribute to the design and implementation of cross-functional strategic, process, and improvement initiatives.
• Expertise in the designated TA with understanding of the specific operational challenges of the TA.
• Digital & AI Leadership: Proven experience implementing digital solutions (AI, automation, and predictive analytics) to modernize clinical operations.
• Regulatory & Quality Rigor: Strong knowledge of GCP/ICH and global regulatory expectations.
• Proven history of developing talent and building robust talent pipelines.
• Matrix Influence: Exceptional executive presence with the ability to break down silos, influence without direct authority, and drive alignment across complex global R&D teams.

Skills

• Required Skills: Artificial Intelligence (AI), Clinical Development, Clinical Trial Planning, Clinical Trials, Digital Leadership, Executive Leadership, Global Team Collaboration, Good Clinical Practice (GCP), ICH GCP Guidelines, Key Performance Indicators (KPI), Matrix Leadership, Ophthalmology, Regulatory Requirements, Strategic Leadership
• Preferred Skills: (Not specified beyond required skills)

Pay

The salary range for this role is $255,800.00 - $402,700.00. An employee’s position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

• Comprehensive package of benefits including medical, dental, vision healthcare, and other insurance benefits (for employee and family).
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.

More information about benefits is available at Merck Compensation and Benefits.