Brian J. Burns

Brian J. Burns Email and Phone Number

General Counsel | Action Behavior Centers I Chief Compliance Officer, Privacy Officer I Legal, Compliance, Privacy, Advocacy, Government Relations, Policy and Public Relations Partner | Patient-Focused Healthcare Company @ Action Behavior Centers - ABA Therapy for Autism
texas, united states
Brian J. Burns's Location
Denver, Colorado, United States, United States
Brian J. Burns's Contact Details
About Brian J. Burns

Legal executive with 20 years of broad healthcare experience. Strategic thought partner and trusted C-suite advisor. Passion for building teams and developing colleagues who lead and support the legal, compliance and related functions for healthcare companies. corporate governance | people services | human resources | litigation | real estate | healthcare operations | healthcare regulatory | healthcare compliance | pharma | biotech | research & development | HIPAA compliance | privacy | internal investigations | government investigations | provider relationships and peer review | patient relations | payer relations, payer contracting & value-based arrangements | transactions | mergers & acquisitions | procurement | vendor relations | public policy | advocacy | government relations | public relations

Brian J. Burns's Current Company Details
Action Behavior Centers - ABA Therapy for Autism

Action Behavior Centers - Aba Therapy For Autism

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General Counsel | Action Behavior Centers I Chief Compliance Officer, Privacy Officer I Legal, Compliance, Privacy, Advocacy, Government Relations, Policy and Public Relations Partner | Patient-Focused Healthcare Company
texas, united states
Employees:
413
Brian J. Burns Work Experience Details
  • Action Behavior Centers - Aba Therapy For Autism
    General Counsel
    Action Behavior Centers - Aba Therapy For Autism Sep 2021 - Present
    Austin, Tx
    Established and continue to grow and support the team of attorneys and other related professionals who are responsible for providing all legal, compliance, investigations, privacy, people services, public policy, and public relations support for best-in-class, patient-focused ABA provider.
  • Davita Kidney Care
    Vice President, Associate General Counsel
    Davita Kidney Care Nov 2017 - Sep 2021
    Greater Denver Area
    Built, developed and supported a team of 15 attorneys and legal professionals responsible for providing legal support to DaVita’s subsidiaries: Nephrology Care Alliance, DaVita Labs, Nephrology Practice Solutions, Lifeline Vascular Care (divested 2020), DaVita Clinical Research, DaVita Hospital Services and Patient Pathways, reporting directly to Group Vice President, Deputy General Counsel As a senior member of DaVita’s legal department, assisted with administrative duties, implemented strategic goals and initiatives and identified and implement best practices across lanesAs a senior member of DaVita’s healthcare regulatory lane within the legal department, advised the management teams of DaVita and its subsidiaries on issues related to value-based care arrangements, physician relationships, practice acquisitions, operations, investigations, litigation, privacy, research and development, real estate, human resources, mergers and acquisitions, commercial contracting, billing and revenue operations, etc. with a concentration on healthcare regulatory and compliance issues including issues related to the Anti-Kickback Statute, False Claims Act, the Stark Law, government inquiries, CAP/CLIA, Qui Tam complaints and compliance with DaVita’s Corporate Integrity AgreementPartnered with DaVita’s compliance department to develop, implement, and provide ongoing support to, subsidiary compliance programs including the development of a referral source arrangement review process designed to ensure compliance with applicable healthcare laws and regulations including the Anti-Kickback StatuteServed as counsel for DaVita’s Innovation group including collaborations and alliances with industry partners and academic institutions for pharmaceutical and medical device development, predictive algorithm development, assay development, biomarker identification, etc.Drafted/reviewed marketing materials, press releases, SEC disclosures, website content and other public disclosures
  • Davita Kidney Care
    Group General Counsel, Senior Director - Labs, Clinical Research And Lifeline Vascular Care
    Davita Kidney Care Aug 2016 - Nov 2017
    Denver, Colorado
    Served as general counsel for DaVita Clinical Research, DaVita Labs and Lifeline Vascular Care (formerly Lifeline Vascular Access); managed a team of attorneys and legal professionals
  • Davita Kidney Care
    Group General Counsel, Senior Director - Labs And Clinical Research
    Davita Kidney Care Feb 2014 - Aug 2016
    Denver, Colorado
    Served as general counsel for DaVita Clinical Research and DaVita Labs; managed a team of attorneys and legal professionals
  • Davita Kidney Care
    Assistant General Counsel, Director - Labs And Clinical Research
    Davita Kidney Care Feb 2013 - Feb 2014
    Denver, Colorado
    Served as general counsel for DaVita Clinical Research and DaVita Labs; managed a team of attorneys and legal professionals
  • Astellas Pharma
    Senior Corporate Attorney
    Astellas Pharma Dec 2011 - Feb 2013
    Northbrook, Il
    Served as in-house counsel to Astellas affiliates including Astellas Pharma Global Development, Inc. and Astellas Scientific and Medical Affairs, Inc. reporting directly to the Associate General Counsel, R&DServed as lead counsel for the Astellas Pharma Global Development, Inc. oncology group Offered counsel to internal clients on various issues related to contracts, international clinical operations, alliances and partnerships, licensing, business development, regulatory matters and complianceDrafted and negotiated contracts including Collaboration Agreements, CRO Master Service Agreements, Work Orders, Change Orders, Letters of Intent, Confidentiality Agreements, Clinical Trial Agreements (including international Clinical Trial Agreements and Investigator Initiated Trials), Laboratory Service Agreements, Consulting Agreements, Speaker Agreements, Advisory Board Agreements, etc.Lead effort to revise Clinical Trial Agreement templates, processes and procedures globally allowing for faster study start up including training of internal clients and the Functional Service Provider CRO responsible for management of the Clinical Trial Agreement negotiation processNegotiated multiple Master Service Agreements and Work Orders for Functional Service Provider CRO relationships as Astellas looked to outsource pre-clinical and clinical research activities on a large scale with small number of CROsServed as lead counsel for Astellas' first Expanded Access Program and Named Patient Program for XTANDI (enzalutamide) working closely with in-house regulatory attorneys and outside counselDrafted and reviewed press releases, website materials and clinical trial recruitment materialsLiaised closely with in-house regulatory and commercial attorneys as investigational compounds were submitted for regulatory approval and preparations were being made for product launchManaged paralegals responsible for negotiating agreements globally
  • Sanofi-Aventis
    Corporate Counsel
    Sanofi-Aventis Sep 2010 - Nov 2011
    Bridgewater, Nj
    Served as in-house counsel for sanofi-aventis US Inc.'s Research and Development Division reporting directly to Vice President & General Counsel, U.S. Research and Development Division Served as counsel to internal clients on various issues related to contracts, clinical trials, alliances and partnerships (including academic and sponsor partnerships), licensing, business development, regulatory and compliance, etc.Drafted and negotiated contracts including Collaboration Agreements, Partnership Agreements, License Agreements, Material Transfer Agreements, CRO Master Service Agreements, Work Orders, Change Orders, Manufacturing Agreements, Letters of Intent, Confidentiality Agreements, Clinical Trial Agreements, Laboratory Service Agreements, Consulting Agreements, Speaker Agreements, Advisory Board Agreements, etc.Served as lead counsel on all Information Technology related License and Service Agreements
  • Gemin X Pharmaceuticals  (Acquired By Cephalon/Teva)
    Contracts Manager
    Gemin X Pharmaceuticals (Acquired By Cephalon/Teva) Jan 2008 - Sep 2010
    Malvern, Pa
    Served as part of the small core team of employees that completed a successful Phase II clinical trial and due diligence process which resulted in Gemin X being acquired by Cephalon, Inc.Served as in-house counsel for business development, clinical operations and drug development issuesManaged all contracts, reporting directly to the Chief Financial OfficerDrafted and implemented contract management SOP’s, including training all staff prior to implementationDrafted and negotiated all contracts for all functional areas including CRO Master Service Agreements, Work Orders, Change Orders, Manufacturing Agreements, Letters of Intent, Confidentiality Agreements, Engagement Letters, Clinical Trial Agreements, Laboratory Service Agreements, Material Transfer Agreements, Licensing Agreements, Share Purchase Agreements, etc.Identified legal and business risks in all contracts and worked with the management team as necessary to address those risksManaged dispute resolution process and negotiated settlements by liaising with management team, vendors and outside counsel when necessaryNegotiated Phase II oncology clinical trial budgetsSupervised and managed CRO negotiation of Clinical Trial Agreements and clinical trial budgets for international clinical oncology sitesManaged grants administration process for all clinical sitesAssisted management team throughout the due diligence process including organization of all relevant documents, negotiation of relevant agreements, etc.
  • Omnicare Clinical Research (Now Theorem Clinical Research)
    Manager, Agreements
    Omnicare Clinical Research (Now Theorem Clinical Research) Mar 2004 - Jan 2008
    King Of Prussia, Pa
    Held multiple positions of increasing responsibility in the Agreements department ultimately being promoted to Manager, AgreementsSupervised team of Contract Negotiators (attorneys) and Study Initiation Services staff membersDrafted and negotiated clinical site related agreements globally for Phase I-IV clinical trials including Clinical Trial Agreements, Confidentiality Agreements, Indemnification Letters, Facility Letters, Agency Letters, Amendments, etc.Recommended language and budget negotiation parameters to Sponsors based on past experienceTrained staff on template usage and negotiation parametersNegotiated clinical trial budgets for Phase I-IV clinical trialsLiaised with Sponsors, Project Directors, Grants Management, and other global team members during Clinical Trial Agreement and clinical trial budget negotiation processReviewed Informed Consents, 1572s and other essential documentsRecognized revenue and worked with Finance Department and Business Development Department to issue change orders to Sponsors when appropriate

Brian J. Burns Skills

Clinical Trials Clinical Development Cro Biotechnology Pharmaceutical Industry Clinical Research Oncology Lifesciences Contract Negotiation Drug Development Gcp Intellectual Property Pharmaceutics Medical Devices Corporate Law R&d Due Diligence Pharmacovigilance Sop Life Sciences Technology Transfer Fda Patents Regulatory Affairs Regulatory Submissions Biopharmaceuticals Regulatory Requirements Ctms Clinical Operations Licensing Drug Discovery Contract Law Therapeutic Areas Medical Affairs Commercialization Infectious Diseases Vaccines Medical Writing Mergers And Acquisitions Partnering Mergers Pharmaceuticals Clinical Pharmaceutical Development Product Development

Brian J. Burns Education Details

Frequently Asked Questions about Brian J. Burns

What company does Brian J. Burns work for?

Brian J. Burns works for Action Behavior Centers - Aba Therapy For Autism

What is Brian J. Burns's role at the current company?

Brian J. Burns's current role is General Counsel | Action Behavior Centers I Chief Compliance Officer, Privacy Officer I Legal, Compliance, Privacy, Advocacy, Government Relations, Policy and Public Relations Partner | Patient-Focused Healthcare Company.

What is Brian J. Burns's email address?

Brian J. Burns's email address is bj****@****hoo.com

What is Brian J. Burns's direct phone number?

Brian J. Burns's direct phone number is +130387*****

What schools did Brian J. Burns attend?

Brian J. Burns attended Widener University School Of Law, Penn State University, Cardinal O'hara High School - Springfield, Pa.

What skills is Brian J. Burns known for?

Brian J. Burns has skills like Clinical Trials, Clinical Development, Cro, Biotechnology, Pharmaceutical Industry, Clinical Research, Oncology, Lifesciences, Contract Negotiation, Drug Development, Gcp, Intellectual Property.

Who are Brian J. Burns's colleagues?

Brian J. Burns's colleagues are Kofi Emmons, Janet Leyva, M.s., Bcba, Lba, Alejandro Martinez, M.ed., Rbt, Megan Osteen, Hannah Thibodaux, Jadah Mata, Will Snell.

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