Executive Director, Head, Global Trial Optimization

MSD • Rahway, NJ

2d • Hybrid

About The Position

The Head of Global Trial Optimization (GTO) provides vision, leadership, oversight, mentoring and coaching to senior GTO staff and oversees the production of GTO deliverables. The role is accountable for optimizing organizational design, resources, key processes, talent and succession management, the operating budget, and high-priority programs and studies. It ensures deliverables meet regulatory, business and patient-centricity standards and that functional contributions support strategic approaches rather than transactional tasks. The role serves as the GTO subject matter expert and promotes data-driven feasibility and recruitment and retention strategies.

The Head communicates program and trial progress, status, mitigation plans and escalations to senior management; leads and coaches the GTO leadership team; and ensures quality program reviews, feasibility assessments, allocation plans, recruitment strategies and issue resolution across the portfolio. The role oversees the use of Real World Data in trial execution simulations, identifies and mitigates portfolio-level risks, supports trial execution through enterprise vendors and standardized digital approaches, and drives compliance with the GCTO Country footprint strategy.

The role also provides strategic and operational oversight of Trial Engagement and Site Partnership, developing integrated strategies to strengthen investigator and site relationships and improve site experience and trial execution. It partners with GCTO colleagues and other internal and external stakeholders to develop processes and innovations for end-to-end clinical trial execution, determine resource needs, monitor industry and regulatory developments, and drive continuous improvement using performance metrics. It may lead operational components of mergers and acquisitions and process-improvement or strategic initiatives.

The position is based primarily in Rahway, New Jersey, with a hybrid work arrangement and 25% travel. Relocation and visa sponsorship are available. The role is regular employee status and eligible for an annual bonus and long-term incentive, if applicable.

Requirements

• Bachelor of Science or Bachelor of Arts degree; an advanced degree is preferred.
• At least 15 years of clinical research experience in the pharmaceutical industry, in the US and ex-US.
• Strong understanding of and commitment to company leadership principles, with emphasis on collaboration, rapid and disciplined decision-making, 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.
• Digital proficiency, including sponsoring enterprise-level digital, analytics, automation-enabled and approved AI-enabled capabilities and using data-driven insights for 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, with the ability to anticipate organizational needs and guide long-term clinical operations decisions.
• Flexible and agile mindset, and ability to foster agility, innovation and continuous improvement in response to changing business, regulatory, technology and portfolio demands.
• Ability to own governance frameworks, escalation pathways and outcomes within delegated authority and enterprise expectations.
• Entrepreneurial ability to identify organizational opportunities through knowledge of the pipeline, patient and investigator landscape, health systems and external environment, and to align pipeline, platforms, policy and people.
• Ability to set strategy and execution direction, define portfolio and capability priorities, make investment and resource choices, establish scenarios and governance, translate strategy into measurable outcomes, and reallocate resources to protect pipeline delivery, quality and organizational capability.
• Ability to influence senior internal and external stakeholders, build strategic partnerships and represent the organization in discussions and governance forums across research, GCD, GCTO, countries, institutions, investigators and vendors.
• Knowledge and experience in project management or Site Ready support.
• Knowledge 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.
• Required skills include Clinical Research Organizations (CRO) Management, Clinical Trials Operations, Cross-Cultural Awareness, Flexibility (Inactive), Influence, People Leadership, Resource Allocation, Results-Oriented, and Strategic Thinking.

Nice To Haves

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

Responsibilities

• Provide vision, leadership, oversight, mentoring and coaching to senior GTO staff and the GTO leadership team.
• Optimize GTO organizational design, resources, processes, talent and succession management, and operating budget.
• Oversee high-priority programs and studies and ensure assigned deliverables meet regulatory, business and patient-centricity standards.
• Implement forward-thinking approaches to improve quality and ease of compliance, and promote strategic rather than transactional contributions.
• 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.
• Ensure quality generation of program reviews, program and trial feasibility assessments, allocation plans, 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 through streamlined enterprise-level vendors where needed and standardized digital presence, while allowing customization of tactics as appropriate.
• Drive compliance with the GCTO Country footprint strategy and adapt processes to changing business conditions and internal or external challenges.
• Provide strategic and operational oversight of Trial Engagement and Site Partnership, with fit-for-purpose strategies that strengthen investigator and site relationships and improve site experience, screening, enrollment, retention and trial execution.
• Partner with GCTO members to develop strategies and processes that enable innovations in end-to-end clinical trial execution.
• 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 and establish and monitor performance metrics to improve predictability, accuracy, capabilities and quality of deliverables.
• May lead operational components of mergers and acquisitions, including due diligence and portfolio integrations.
• May lead or implement process-improvement and strategic initiatives.

Benefits

• Medical insurance and other healthcare and insurance benefits for employees and family.
• Dental insurance.
• Vision insurance.
• Retirement benefits, including 401(k).
• Paid holidays.
• Vacation.
• Compassionate and sick days.
• Annual bonus eligibility.
• Long-term incentive eligibility, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive