Tiffany Green
Senior Director, Clinical Research and Development Counsel @Crinetics Pharmaceuticals
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WORK HISTORY
Senior Director, Clinical Research and Development Counsel @Crinetics Pharmaceuticals
o Provide legal advice, education, and actively resolve legal issues related to Clinical Trial execution, including GxP compliance, diversity in clinical trials, subject recruitment and retention, decentralized trials, patient safety and pharmacovigilance, informed consent, and research privacy, etc.o Global Clinical Trial Agreement Executiono Lead the implementation of a global CTA template libraryo Participate in CRC review of all clinical trial and investigational drug-related materialso Identify and eliminate any friction or potential inefficiencies in supporting Crinetics global clinical trial operationso Participate in governance and committee meetings focused on internal quality metrics, operational oversight, and site or project reviews.o Collaborate with Quality and Regulatory teams to develop corrective and preventive action plans (CAPAs) and formal responses following regulatory inspections, observations, or inquiries.o Assist in developing materials for regulatory meetings and preparing teams participating in such meetings.o Provide guidance on product quality incidents and post-marketing reporting obligations and actions.o Work cross functionally with Quality, Regulatory, and other stakeholders to advise on and support process and systems improvements, including development of global quality policies and training materials.o Draft and edit written reports, presentations, and other communications for internal and external audiences related to regulatory and GxP compliance.o Monitor the external legal and regulatory environment, advising internal stakeholders on emerging GxP and quality-related policy developments.o Oversee policies and procedures for the law group, and design policies for cross functional legal departments as they pertain to research and development.
EDUCATION
Florida State University
Bachelor of Science, Criminology and Criminal Justice
Campbell University, Norman Adrian Wiggins School of Law
Doctor of Law (JD)
SKILLS
ABOUT TIFFANY GREEN
Energetic, business-focused attorney with over a decade of experience in the biotech and pharmaceutical industry, with deep expertise in negotiating and drafting a wide range of complex agreements, including clinical trial agreements, master agreements, vendor contracts, and confidentiality agreements. Adept at aligning legal strategy with business goals to drive results, mitigate risk, and streamline operations. Recognized for delivering practical, risk-balanced legal advice across cross-functional teams. Proven leader in contract lifecycle management, process improvement, and metric improvement. Brings a strategic mindset, commercial acumen, and a collaborative approach to legal partnership. Demonstrated expertise in advising on state and federal research regulations, ICH CGP guidelines, and global multi-center clinical trials.Licensed in North Carolina and Florida.
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