Executive Director, Head, Global Trial Optimization

Merck2 Locationsonsite$256k–$403kView the original posting at Merck ↗

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 foste

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