Executive Director, Head, Global Trial Optimization

MSD•Rahway, NJ

3d•$255,800 - $402,700•Hybrid

About The Position

The Head of Global Trial Optimization (GTO) provides vision, leadership, oversight, mentoring, and coaching to senior GTO staff. The role oversees the production of GTO deliverables and continual optimization of organizational design and resources, key processes, talent and succession management, the operating budget, and high-priority programs and studies. The position ensures deliverables meet regulatory, business, and patient-centricity standards, and that functional contributions support strategic approaches. It advances data-driven feasibility and recruitment and retention strategies, communicates progress and escalations to senior management, and provides portfolio-wide leadership for feasibility, allocation, recruitment planning, risk mitigation, and issue resolution. The role also supports trial execution through enterprise-level vendors, standardized digital capabilities, and adaptable tactics; drives compliance with the GCTO Country footprint strategy; and oversees Trial Engagement and Site Partnership strategies to strengthen investigator and site relationships and support trial execution. The Head collaborates with internal and external stakeholders, including CSSM, CQM, Country Operations, GPAM, Clinical Directors, and Legal, to anticipate and address study needs. The position determines resource needs in collaboration with leaders, monitors industry practices and regulatory requirements, drives continuous improvement, and establishes performance metrics. It may also lead operational components of mergers and acquisitions and process-improvement or strategic initiatives.

Requirements

Bachelor of Science or Arts degree.
At least 15 years of clinical research experience in the pharmaceutical industry, in the US and outside the US.
Strong understanding of and commitment to the company's Leadership principles, particularly collaboration, rapid and disciplined decision-making, and integrity and ethics.
Strong written and spoken English communication skills, including the ability to influence and represent the organization at senior regional and global levels.
Ability to sponsor enterprise-level digital, analytics, automation-enabled, and approved AI-enabled capabilities and use data-driven insights to shape portfolio, organizational, and resource strategy.
Ability to establish and govern risk-informed decision frameworks across the portfolio, balancing quality, compliance, business objectives, resources, and strategic priorities.
Enterprise-level critical thinking and judgment in complex and ambiguous situations, including anticipating organizational needs and guiding long-term clinical operations decisions.
Ability to build agility, innovation, and continuous improvement and respond proactively to changing business, regulatory, technology, and portfolio demands.
Ability to own governance frameworks, escalation pathways, and outcomes within delegated authority and enterprise expectations.
Ability to identify and champion opportunities using knowledge of the pipeline, patient and investigator landscape, health systems, and external environment; align pipeline, platforms, policy, and people; and direct innovation and operating-model choices.
Ability to set strategy and execution direction, define portfolio and capability priorities, make investment and resource choices, establish scenarios and governance, translate direction into measurable execution standards, and reallocate resources to protect pipeline delivery, quality, and organizational capability.
Ability to influence senior internal and external stakeholders, build partnerships, represent the organization in strategic discussions and governance forums, and advance clinical research outcomes across the research division, GCD, GCTO, countries, institutions, investigators, and vendors.
Knowledge and experience in project management or Site Ready support.
Knowledge of and ability to apply GCP/ICH and applicable regulatory guidelines.
Superior presentation skills.
Training and curriculum development experience.
Computer skills, including proficiency in data analysis and presentation software, Microsoft Word, and Excel.
Clinical Research Organizations (CRO) management, clinical trials operations, cross-cultural awareness, flexibility, influence, people leadership, resource allocation, results orientation, and strategic thinking.

Nice To Haves

Advanced degree.
Proficiency with data modelling software where applicable.
Process management experience.
International collaboration experience.
Sigma training.

Responsibilities

Provide vision, leadership, oversight, mentoring, and coaching to senior GTO staff and the GTO leadership team.
Ensure assigned deliverables meet regulatory, business, and patient-centricity standards and advance strategic rather than transactional work.
Implement forward-thinking approaches to improve quality and ease of compliance.
Lead data-driven feasibility and development of recruitment and retention strategies.
Communicate progress, status updates, mitigation plans, and escalations for trial- and program-level deliverables to senior management.
Oversee quality generation of Program Reviews, program and trial feasibility, allocation, recruitment strategies, plans, and tactics, and resolve issues across the portfolio.
Ensure staff are trained to use Real World Data in trial execution simulations based on protocol and patient knowledge and collaboration with PDT members.
Identify portfolio-level risks and ensure risk mitigation strategies are developed and implemented across programs.
Support trial execution by implementing streamlined enterprise-level vendors where needed and standardizing digital presence while allowing customized tactics as needed.
Drive compliance with the GCTO Country footprint strategy and adapt processes as business conditions evolve.
Provide strategic and operational oversight of Trial Engagement and Site Partnership, developing fit-for-purpose strategies that strengthen investigator and site relationships and support trial screening, enrollment, retention, and execution.
Partner with GCTO team members to develop strategies and processes for end-to-end clinical trial execution innovations.
Collaborate with CSSM, CQM, Country Operations, GPAM, Clinical Directors, Legal, and other stakeholders to anticipate and address study needs.
Determine resource needs by reviewing authorized and anticipated clinical development activities and collaborating with CSSM and GPAM leaders.
Stay current on pharmaceutical industry best practices, regulatory requirements, and corporate strategies affecting the organization.
Drive continuous improvement in GTO to improve predictability and accuracy of deliverables.
Collaborate to establish performance metrics and monitor them to enhance capabilities and overall quality.
May lead operational components of mergers and acquisitions, including due diligence and portfolio integrations.
May lead or implement process-improvement and strategic initiatives.