Executive Director, Head, Global Trial Optimization

Job description

Job Description Job Summary The Head of Global Trial Optimization (GTO) provides vision, leadership, oversight, mentoring and coaching of senior GTO staff in producing GTO deliverables. This includes continual optimization of the organizational design and resources, ownership and optimization of key processes, talent and succession management, overall operating budget management and oversight of all high priority programs and studies. Primary Activities/Responsibilities Accountable for ensuring that assigned deliverables meet regulatory, business, patient-centricity standards (as appropriate) that all functional contributions drive towards strategic approaches versus transactional tasks. Responsible for implementing forward-thinking philosophies to improve quality and increase ease of compliance. Subject matter expert for the GTO. Provide vision, leadership and oversight of the GTO group in implementing data driven approaches to feasibility and development of recruitment and retention strategies. The Head, GTO is accountable for the communication of progress, status updates, mitigation plans and escalation of issues for trial or program level deliverables to Sr. Management. Provide strategic leadership, coaching and people management for the GTO leadership team, with accountability for quality deliverable generation (i.e., Program Review, Program/Trial Feasibility, Allocation, and Recruitment strategies, plans, and tactics) and issue resolution across the portfolio. Ensure staff are trained to apply Real World Data as inputs into trial execution simulations based on protocol/patient knowledge and collaborations with PDT members. Accountable for identifying portfolio-level risks and ensuring appropriate risk mitigation strategies are developed and implemented across programs. Provide trial execution support by implementing streamlined enterprise level vendors where needed and standardizing the digital presence while retaining flexibility to customize tactics as needed. They will drive compliance with the GCTO Country footprint strategy and respond to internal/external challenges by evolving and adapting the process as the business landscape evolves. Provide strategic and operational oversight of the Trial Engagement and Site Partnership organization, ensuring integrated, fit-for-purpose strategies that strengthen investigator and site relationships, improve the site experience, and support trial screening, enrollment, retention and execution. Partner with GCTO team members to develop strategies, processes to enable key GCTO innovations in end-to-end clinical trial execution. Have an established network both internal and external to our company and will be expected to work in close collaboration with CSSM, CQM, Country Operations, GPAM, Clinical Directors, Legal and other key stakeholders to ensure all are equipped with the ability to anticipate the needs of upcoming studies and expeditiously address study needs. Determination of resource needs through the review of authorized and anticipated clinical development activities and close collaboration with CSSM and GPAM leaders. Keeping abreast of pharmaceutical industry best practices, regulatory requirements and corporate strategies that impact the organization. Responsible for driving continuous improvement within GTO to optimize predictability and accuracy of deliverables. Collaborates to establish performance metrics and monitors these metrics to continually enhance capabilities and improve overall quality. May lead operational components of mergers and acquisitions (e.g., due diligence activities, portfolio integrations). May lead and/or implement process improvement and strategic initiatives. Required: Bachelor of Science/Arts; advanced degree preferred Required Experience and Skills: A minimum of 15 years clinical research experience in pharmaceutical industry (US and exUS) Strong understanding and dedication to our company's Leadership principles, with an emphasis on fostering collaboration, rapid/disciplined decision-making and integrity/ethics. Strong communication skills requiring proficiency in written and spoken English. The incumbent must be competent and effective in written and verbal communication, including the ability to influence and represent the organization at senior regional and global levels. Digital Proficiency: Sponsors enterprise-level digital, analytics, automation-enabled and approved AI-enabled capabilities and uses data-driven insights to shape portfolio, organizational and resource strategy. Risk-Based Decision-Making & Leadership: Establishes and governs risk-informed decision frameworks across the portfolio, balancing quality, compliance, business objectives, resources and strategic priorities. Critical Thinking: Applies enterprise-level judgment to complex and ambiguous situations, anticipates future organizational needs and guides strategic decisions impacting long-term clinical operations performance. Flexible / Agile Mindset: Builds a culture of agility, innovation and continuous improvement, enabling proactive response to evolving business, regulatory, technology and portfolio demands. Accountability & Decision Rights: Owns governance frameworks, escalation pathways and outcomes within delegated authority and enterprise expectations. Entrepreneurship: Creates and champions opportunities for the organization by applying deep knowledge of the pipeline, patient and investigator landscape, health system and external environment; aligns pipeline, platforms, policy and people, embeds end-to-end ownership and directs innovation and operating-model choices that strengthen competitiveness and patient access to trials. Strategic Planning & Execution Excellence: Sets strategy and execution direction, defining portfolio and capability priorities, investment and resource choices, scenarios, “what must be true” conditions, trade-offs and governance; translates direction into execution standards and measurable outcomes and reallocates resources to protect pipeline delivery, quality and long-term organizational capability. Enterprise Relationship Management & Partnerships: Influences senior internal and external stakeholders and champions the global trial optimization network required for clinical operations success across our company's research division, GCD, GCTO, countries, institutions, investigators, and vendors; builds high-value partnerships, represents the organization in strategic discussions and governance forums, and shapes accountabilities that reduce silos and advance capability, pipeline delivery and clinical research outcomes. Project Management or Site Ready support knowledge and experience Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines Superior presentation skills Training and curriculum development Computer skills including proficiency in aspects of data analysis and presentation software, Microsoft Word and Excel. Preferred Experience: Proficiency with data modelling software where applicable. Process management International collaboration Sigma training Required Skills: Clinical Research Organizations (CRO) Management, Clinical Trials Operations, Cross-Cultural Awareness, Flexibility (Inactive), Influence, People Leadership, Resource Allocation, Results-Oriented, Strategic Thinking Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability