Transforming biopharmaceutical research through innovative data strategies and leadership in Clinical Data Management.
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ED | VP, Clinical Data Management
Seasoned pharmaceutical executive with extensive experience in Clinical Data Management (CDM), analytics and programming within the biopharmaceutical industry. Proven track record of leading cross-functional teams to deliver high-quality CDM solutions that accelerate drug development and ensure regulatory compliance.
My superpower? Making complex data concepts accessible to everyone from scientists to CEOs. I am passionate about data standards, process optimization, and mentoring the next generation of data professionals.
Therapeutic Areas
Clinical Trials
CDM Functions Built
Acquisitions
Head of CDM at clinical-stage biotechs since 2017
faster database lock
Pivotal Phase III, CymaBay
faster topline results
BI framework, CymaBay
faster database lock
Process redesign, Arena
fewer queries
25+ trials, Ionis
Full resume available on request. Earlier roles are on LinkedIn.
The vision
Across the portfolio, clinical data the company can act on at every milestone: interim, lock, topline, filing.
Reliable, decision-ready data behind every major program decision.
Data planned around every milestone that depends on it, through submission.
Quality built in so audits and inspections confirm controls that are already in place.
A focused in-house team with the right mix of internal and partner capacity.
Strategic governance plan so outsourced work stays on time and on quality.
One integrated, near real-time view of the data, built on BI and AI tools.
The shift
Decisions left to the CRO
Decisions owned by the sponsor
Data cleaned at the end
Data ready at every milestone
Separate reports by function
One shared view of the data
How it adapts to a company's stage, portfolio and partners is what I walk through in conversations.
Let's talkThe skills I have mastered to fight the forces of messy data and inefficient processes
Building and mentoring high-performing global CDM teams, fostering collaboration across functions, and creating a culture of continuous improvement and innovation.
Developing comprehensive data strategies aligned with clinical development objectives, ensuring data quality, integrity, and regulatory compliance throughout the drug development lifecycle.
Ensuring adherence to FDA, EMA, ICH-GCP, and other regulatory requirements, with expertise in CDISC standards (C-DASH, SDTM, ADaM, ODM), 21 CFR Part 11, and data privacy regulations.
Deep understanding of oncology, rare diseases, immunology, inflammatory pain, hepatology and cardiovascular therapeutics, with ability to tailor data strategies to specific therapeutic area requirements.
Implementing lean methodologies and digital solutions to streamline clinical data processes, reduce cycle times, and improve operational efficiency without compromising quality.
Leveraging advanced analytics, machine learning, gen AI, and visualization techniques to derive actionable insights from clinical trial data, supporting evidence-based decision making.
High-profile recognitions for my data wizardry over the years
Recognized for pioneering the implementation of a Business Intelligence framework for real-time clinical data quality monitoring, driving significant improvements in data accuracy and reducing time to top-line results, ultimately enhancing data-driven decision-making in clinical research.
Acknowledged for leadership during the COVID-19 pandemic, establishing a decision framework to preserve eCOA (ePRO ClinRO) data integrity across three critical clinical programs, ensuring reliability, continuity, and scientific validity amid unprecedented challenges.
Recognized for development and deployment of a responsive mobile/web platform integrating patient profile-based outcomes from nine pivotal NSCLC studies, accelerating evidence-driven HCP communication and optimizing access to critical clinical insights for informed decision-making.
Recognized for establishing the Design & Technology Lab in U.S. Medical Affairs, delivering two digital solutions through exceptional design and engineering. These innovations forged new MCO collaboration pathways, rapidly identifying evidence gaps to inform strategy for marketed drugs.
Want to discuss how I can help with your data challenges? Drop me a message!
I'm all ears (well, metaphorically)
I am always excited to connect with fellow data enthusiasts, potential collaborators, or anyone interested in advancing pharmaceutical data science.
(650) 477-0119
San Mateo, California, USA