Lyn Mursalo
Director, Clinical Operations
Irvine,CA
Summary
Results-driven Clinical Research Professional with over 27 years of experience in clinical operations within pharmaceutical, biotechnology, and CRO settings. Demonstrated expertise in overseeing Phase I-III clinical trials, ensuring efficient and timely completion. Skilled in collaborating with global project teams, stakeholders, and vendors to achieve successful study outcomes while upholding high standards of quality and regulatory compliance. Known for innovation and leadership in implementing and guiding clinical study teams with strategic and tactical direction.
Overview
31
31
years of professional experience
Work History
Associate Director/Director, Clinical Operations
Escient Pharmaceuticals
09.2021 - 05.2025
- Lead Escient's clinical trials to ensure timely and compliant implementation and execution.
- Facilitated cross-functional collaboration within the organization for improved decision making processes within the organization.
- Strategic selection of CROs and other study vendors, maintaining strong vendor relationships to ensure they remain within timelines and budget and to optimize study efficiency.
- Develop and drive clinical program timelines to align with corporate goals, engaging with internal and external stakeholders to identify potential challenges, mitigate delays and ensure accelerated clinical trial implementation.
- Managed study budgets to ensure optimal forecasting and resource planning.
- Proactively identified potential risks and implemented mitigation strategies to minimize negative impacts on projects.
- Provide operational input for study documents in support of trial execution including protocols, informed consent forms, source document worksheets etc.
- Collaborate with CRO and clinical trial scientists to select experienced, high performing study sites and proactively identify enrollment challenges.
- Maintained effective working relationships with investigators and study site research coordinators.
- During my time at Escient, I led a Phase 1 study to completion within expedited timelines. I simultaneously oversaw two early phase trials in USA, Canada and Europe with a combined budget of over $25 million achieving on-time database lock for both.
- Delivered on goals contributing to the successful acquisition of the company.
Associate Director, Clinical Monitoring
Clinipace (now Caidya)
02.2021 - 08.2021
- Strategic leadership and growth of the clinical trial monitoring group, ensuring the delivery of quality clinical operations services.
- Predicted resource requirements and appointed CTMs with proven skillsets to support and manage new and ongoing clinical trials.
- Led a team of up to 10 CTM's, supervising daily performance, establishing performance goals and provided guidance on how to reach those milestones.
- Drove the global integration of clinical operations processes across the organization through review and revision of monitoring processes, plans and SOP's.
- Delivered on business development activities through the provision and delivery of appropriate content at bid defense meetings.
Senior Clinical Trial Manager
Clinipace
Brisbane, Australia & Irvine, CA
01.2018 - 02.2021
- Spearheaded monitoring services for clinical projects.
- Ensured high-quality CRO services through collaboration and clear communication between study teams, sponsors, and investigators to maintain alignment on project goals and expectations.
- Fostered strong relationships with investigative sites, leading to increased collaboration and improved study outcomes.
- Managed and mentored a team of 8 CRAs and CTAs ensuring operational excellence through training, compliance assessments, regular formal communication, and annual performance evaluations.
Clinical Trials Program Manager
Ellume
03.2016 - 12.2017
- Operational oversight of in vitro diagnostic clinical trials achieving on-time recruitment of 500+ participants in Australia.
- Developed study procedures and SOPs ensuring compliance with regulatory requirements.
- Identified program obstacles and communicated possible impacts to team.
Senior Clinical Research Associate
Premier Research
03.2015 - 02.2016
- As the second in-country employee made significant contributions towards pioneering Premier Research's clinical operations in Australia.
Senior Clinical Research Associate (Contract)
Servier Australia
04.2013 - 02.2015
Project Manager
Novotech
12.2011 - 12.2012
- Planning and project management of contracted responsibilities for assigned clinical projects in Australia, New Zealand and South Africa.
Clinical Research Manager
Lundbeck A/S
11.2007 - 10.2011
- Established and implemented critical processes, procedures and SOPs for the conduct of clinical trials in newly established Australia-based office, managing a team of 8 regionally based CRA's/CTA's.
Regional Clinical Research Manager
Merck Sharp and Dohme
08.2001 - 10.2003
- Implemented a regionally based model for monitoring trials thereby increasing efficiency, improving availability of CRA's to study sites and reducing travel costs.
Senior Clinical Research Associate
PPD
08.1999 - 07.2001
Clinical Research Manager, Europe
Biogen
09.1998 - 07.1999
- Contributed to the establishment of European clinical operations for Biogen in London.
Clinical Research Associate
Eli Lilly
01.1994 - 12.1997
Education
Bachelor of Science - Human Genetics
University of The Witwatersrand
Johannesburg, South Africa11-1987
Skills
- Collaborative decision-making
- Program coordination
- Operations management
- Strong written communication skills
- Work Planning and Prioritization
- Budget management
- Team collaboration and leadership
- Staff recruitment and onboarding
- Coaching and development
- Collaborative stakeholder relations
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Work Preference
Work Type
Full TimeWork Location
HybridRemoteImportant To Me
Company CultureFlexible work hoursWork from home optionPaid time offWork-life balanceTeam Building / Company RetreatsPaid sick leave401k matchPersonal development programsLanguages
English
Full Professional
Interests
Hiking, travel, photography
Timeline
Associate Director/Director, Clinical Operations
Escient Pharmaceuticals
09.2021 - 05.2025
Associate Director, Clinical Monitoring
Clinipace (now Caidya)
02.2021 - 08.2021
Senior Clinical Trial Manager
Clinipace
01.2018 - 02.2021
Clinical Trials Program Manager
Ellume
03.2016 - 12.2017
Senior Clinical Research Associate
Premier Research
03.2015 - 02.2016
Senior Clinical Research Associate (Contract)
Servier Australia
04.2013 - 02.2015
Project Manager
Novotech
12.2011 - 12.2012
Clinical Research Manager
Lundbeck A/S
11.2007 - 10.2011
Regional Clinical Research Manager
Merck Sharp and Dohme
08.2001 - 10.2003
Senior Clinical Research Associate
PPD
08.1999 - 07.2001
Clinical Research Manager, Europe
Biogen
09.1998 - 07.1999
Clinical Research Associate
Eli Lilly
01.1994 - 12.1997
Bachelor of Science - Human Genetics
University of The Witwatersrand
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