Lilith Mist
Portland
Summary
Executive Clinical Research Director with extensive experience in global clinical trial operations at Merck. Proven ability to drive digital transformation and enhance effective collaboration across diverse teams. Successfully managed a team of approximately 40 individuals, while ensuring compliance, and consistently delivering results in complex environments.
Overview
29
29
years of professional experience
1
1
Certification
Work History
Executive Clinical Research Director (CRD)
Merck
Portland
07.2020 - Current
- Managed clinical trial operations for approximately 40 interventional trials across Phases I/II to III/IV.
- Oversaw three Clinical Research Directors and up to 38 Clinical Research Managers to optimize performance.
- Drove all aspects of performance and talent management across the team
- Identified and addressed performance issues to uphold high standards across all projects.
- Provided leadership to ensure compliance, quality standards, and timeline objectives for trials.
- Coordinated cross-functional teams to deliver high-quality results within established timelines.
- Developed relationships with key stakeholders, enhancing collaboration on priority projects.
- Led global electronic Investigator Site File initiative, digitizing trial documentation processes.
- Modeled behaviors consistent with Merck Leadership Standard, scoring above band-benchmark on all Ways of Working on 360 review in 2024.
Clinical Research Director (CRD)
Merck
Portland
07.2017 - 07.2020
- Led Primary Care and Vaccine TA franchise activities for U.S. country operations.
- Executed clinical trial portfolio, ensuring successful enrollment and quality.
- Monitored timelines and key milestones to guarantee project success.
- Forecasted personnel needs while managing talent across trials.
- Supported recruiting efforts, conducted performance evaluations, and ensured training compliance.
- Collaborated with Regional Medical Affairs to deliver on critical trials.
Clinical Research Manager (CRM)
Merck
Portland
07.2014 - 06.2017
- Ensured compliance with ICH/GCP, country regulations, and Merck policies for assigned protocols.
- Proactively tracked execution of deliverables to meet commitments for assigned protocols.
- Collaborated with vendors to drive quality on assigned trials.
- Oversaw operational outputs of Clinical Research Associates and Clinical Trial Coordinators.
- Conducted quality control visits to uphold monitoring standards.
- Reviewed and approved monitoring visit reports for accuracy.
- Addressed performance issues and identified training needs, escalating to appropriate teams when necessary.
- Supported the development of local and regional strategies aligned with corporate objectives and CRD.
- Monitored patient recruitment progress and identified strategies for improvement.
Associate Director, Project Management
Merck
Portland
08.2012 - 07.2014
- Managed 7-8 Clinical Project Managers, ensuring alignment with Merck Leadership Standards.
- Directed activities of Clinical Trial Coordinators to ensure smooth trial execution.
- Facilitated objective setting, performance reviews, and development discussions for all direct reports.
- Provided consistent coaching to all direct reports.
- Oversaw overall country-level study management for assigned clinical trials through all phases, achieving study objectives on time.
- Ensured CPMs team fulfilled role as primary liaison between Clinical Project Managers and HQ teams for each study.
- Identified and tracked mitigation plans for challenges encountered during trial execution.
Clinical Research Manager (CRM)
Merck
Portland
06.2010 - 07.2012
- Managed 6-8 Clinical Project Managers, ensuring alignment with Merck leadership standards.
- Drove change management and trial quality during the integration with Schering-Plough.
- Facilitated objective setting, performance reviews, and development discussions for all direct reports.
- Provided consistent coaching to all direct reports.
- Oversaw overall country-level study management for assigned clinical trials through all phases, achieving study objectives on time.
- Ensured the CPM team fulfilled its role as the primary liaison between the CRAs and HQ teams for each assigned study.
- Identified and implemented mitigation plans for challenges in trial execution.
- Supported country activities to achieve targets across all clinical trials.
Sr. US Protocol Manager
Merck
Portland
07.2008 - 05.2010
- Managed protocols at a country level according to ICH-GCP, Merck standards, and local regulations.
- Served as the primary country point of contact for the Clinical Operations Specialist and the Patient Recruitment Specialist.
- Selected sites for trials, including site identification and validation, in coordination with CRAs.
- Liaised with other areas (e.g., Clinical, Medical Affairs) regarding inclusion of sites and dissemination of selection decisions.
- Delivered training to CRAs working on assigned protocols.
- Managed and documented clinical trial progress at the country level, implementing actions to ensure targets were met.
Sr. Clinical Research Associate
Merck
Portland
02.2007 - 06.2008
- Served as primary site contact for investigator site management, addressing operational protocol & quality issues in clinical research studies.
- Managed 15 to 24 sites across multiple protocols using a process-oriented approach.
- Monitored site regulatory documents, data and clinical trial conduct, ensuring compliance with ICH-GCP standards and excellent sponsor oversight.
- Delivered live ICH-GCP and protocol training to site personnel as required.
- Mentored new hire CRAs
Sr. Clinical Operations Specialist (Developmental Assignment)
Merck
10.2006 - 02.2007
- Led global vaccine trials, ensuring successful execution across all phases.
- Coordinated activities among multiple countries to enhance trial efficiency.
- Managed vendor relationships for assigned trials, optimizing collaboration and quality
- With Meeting Management, planned and executed Investigator Meetings and recruitment teleconferences
Sr. Global Project Liaison (Developmental Assignment)
Merck
03.2006 - 10.2006
- Led global vaccine trials, ensuring successful execution across all phases.
- Coordinated activities among multiple countries to enhance trial efficiency.
- Managed vendor relationships for assigned trials, optimizing collaboration and quality
- With Meeting Management, planned and executed Investigator Meetings and recruitment teleconferences
Sr. Medical Research Associate
Merck & Co., Inc.
01.2005 - 03.2006
- Served as primary site contact for investigator site management, addressing operational protocol & quality issues in clinical research studies.
- Managed approximately 22 sites across multiple protocols using a process-oriented approach.
- Monitored site regulatory documents, data and clinical trial conduct, ensuring compliance with ICH-GCP standards and excellent sponsor oversight.
- Delivered live ICH-GCP and protocol training to site personnel as required.
- Mentored new hire CRAs
Medical Research Associate
Merck & Co., Inc.
12.2000 - 12.2004
- Served as primary site contact for investigator site management, addressing operational protocol & quality issues in clinical research studies.
- Managed sites across multiple protocols using a process-oriented approach.
- Monitored site regulatory documents, data and clinical trial conduct, ensuring compliance with ICH-GCP standards and excellent sponsor oversight.
- Delivered live ICH-GCP and protocol training to site personnel as required.
Medical Research Associate, Contractor
Placers/Randstad
07.1999 - 12.2000
- Served as primary site contact for investigator site management, addressing operational protocol & quality issues in clinical research studies.
- Managed sites across multiple protocols using a process-oriented approach.
- Monitored site regulatory documents, data and clinical trial conduct, ensuring compliance with ICH-GCP standards and excellent sponsor oversight.
- Delivered live ICH-GCP and protocol training to site personnel as required.
Clinical Research Coordinator
Summit Research
07.1996 - 07.1999
- Coordinated research activities for psychiatric and Alzheimer's trials, ensuring regulatory compliance.
- Established strong patient relationships, enhancing retention and improving adverse event reporting accuracy.
- Collected and reviewed trial data.
- Executed data entry into electronic data capture systems.
- Maintained essential trial documentation.
- Dispensed investigational products while maintaining strict accountability protocols.
Education
B.A. - Psychology
Yale University
New Haven, CT06.1996
Skills
- Organizational leadership
- Building resilient and high-performing teams
- Strategic planning and execution
- Digital transformation and innovation
- Collaboration and conflict resolution
- Clinical trial and supplier oversight
- Change management
- Excellent written and verbal communication
Accomplishments
- With Finance & Procurement, assessed and executed a supplier contract change order that will result in a projected savings of approximately $10 million between now and 2028
- Merck PASARD Award for iLab innovation (2021)
- Pipeline Awards for exceptional contributions (2019, 2021, 2022)
- Breakthrough Award for Mk4482 (2021)
- Merck Special Achievement Awards (2012, 2014, 2016)
- Key contributor to launch of Merck's Emergency Unblinding Call Center
- Cum Laude / Distinction in the Major, Yale University
Languages
Spanish
Limited
Certification
- ACRP-CP (2024)
References
References available upon request.
Timeline
Executive Clinical Research Director (CRD)
Merck
07.2020 - Current
Clinical Research Director (CRD)
Merck
07.2017 - 07.2020
Clinical Research Manager (CRM)
Merck
07.2014 - 06.2017
Associate Director, Project Management
Merck
08.2012 - 07.2014
Clinical Research Manager (CRM)
Merck
06.2010 - 07.2012
Sr. US Protocol Manager
Merck
07.2008 - 05.2010
Sr. Clinical Research Associate
Merck
02.2007 - 06.2008
Sr. Clinical Operations Specialist (Developmental Assignment)
Merck
10.2006 - 02.2007
Sr. Global Project Liaison (Developmental Assignment)
Merck
03.2006 - 10.2006
Sr. Medical Research Associate
Merck & Co., Inc.
01.2005 - 03.2006
Medical Research Associate
Merck & Co., Inc.
12.2000 - 12.2004
Medical Research Associate, Contractor
Placers/Randstad
07.1999 - 12.2000
Clinical Research Coordinator
Summit Research
07.1996 - 07.1999
B.A. - Psychology
Yale University
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