Diana Genetti
Associate Director, Corporate Counsel @BioMarin Pharmaceutical Inc.
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WORK HISTORY
Associate Director, Corporate Counsel @BioMarin Pharmaceutical Inc.
San Rafael, CA, US
Serve as strategic legal partner to global R&D and Clinical Operations, advising on clinical trial execution, enterprise risk management, and scalable contracting frameworks across Phase I–IV programs supporting pipeline expansion including acquired late-stage pipeline products. Lead negotiation of clinical trial agreements (CTAs), CRO and vendor master services agreements, and data privacy terms (HIPAA/GDPR) for multinational studies.Previously provided comprehensive legal support to Technical Operations across global manufacturing, quality, supply chain, and capital projects supporting a diverse commercial portfolio and late-stage development programs. Negotiated and managed non-disclosure agreements, master services agreements, supply and warehousing agreements, in-licensing and material transfer agreements, construction contracts, and complex development, manufacturing, and packaging agreements.
EDUCATION
UC San Diego
Bachelor of Science (B.S.), Biology, General
University of Maine School of Law
Doctor of Law (JD), Law
SKILLS
ABOUT DIANA GENETTI
Strategic in-house counsel supporting global R&D and clinical study operations in the biopharma industry. Lead legal partner to clinical development and study teams across the full clinical trial lifecycle.Experienced in clinical trial agreements (CTAs), CRO and vendor contracting, master services agreements (MSAs), informed consent, data privacy (HIPAA/GDPR), and GCP-regulated operations. Advise on cross-border clinical research, regulatory compliance, and Phase I–IV trial execution.Trusted advisor to clinical operations, pharmacovigilance, regulatory, data management, and procurement. Skilled in contract strategy, risk assessment, inspection readiness, and scalable legal process development.Significant prior experience supporting technical development, quality, global supply chain, and GMP manufacturing across the product lifecycle, as well as property management including capital projects, commercial leasing, and purchase and sale.
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