Thomas Gnielinski
About Thomas Gnielinski
Thomas Gnielinski serves as the VP of Law Commercial and Compliance at BridgeBio, where he manages data privacy and IT security compliance while advising on various legal matters in the biotech sector. He has extensive experience in healthcare compliance, international anti-corruption laws, and has held senior legal positions at several prominent pharmaceutical companies.
Work at BridgeBio
Thomas Gnielinski serves as the Vice President of Law Commercial and Compliance at BridgeBio. He has held this position since 2021 in Orange County, California. In this role, he manages data privacy and IT security compliance, ensuring adherence to regulations such as HIPAA, GDPR, and CCPA. He also provides guidance on access strategies, including pricing, reimbursement, and patient support programs for biotech and pharmaceutical products.
Previous Experience in Compliance and Law
Prior to his current role, Thomas Gnielinski worked at Ambry Genetics as Vice President of Law and Chief Compliance Officer from 2018 to 2021. He also held the position of Senior Director of Law at Alexion Pharmaceuticals, Inc. from 2014 to 2017, and served as Director of Compliance at Amgen for 11 months in 2013. His earlier experience includes working as Corporate Counsel at Miltenyi Biotec from 2006 to 2007 and various roles at Amgen from 2007 to 2013.
Education and Expertise
Thomas Gnielinski has extensive expertise in drafting and negotiating distribution agreements for biotech products. He specializes in creating and improving Healthcare Compliance Programs tailored for life science companies. His knowledge extends to international anti-corruption laws, including the Foreign Corrupt Practices Act (FCPA) and the UK Bribery Act. He also advises on legal and compliance issues related to the commercialization of diagnostic testing across various regions, including the EU/EEA, CEE, Russia, and the Middle East.
Regulatory Guidance and Compliance Programs
In his professional capacity, Thomas Gnielinski provides expert advice on Fraud and Abuse and Anti-Kickback statutes. He guides marketing and sales teams on regulatory promotion matters, including the review processes for promotional materials. He also prepares for product launches by advising on pre-approval activities in both the US and international markets, ensuring compliance with relevant regulations.