David Jacobs, JD, MA

Experience

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  Bristol-Myers Squibb, Princeton, New Jersey

  Jan 2005 - Jan 2013

  SENIOR COUNSEL, USP/MEA LAW & PROMOTION COMPLIANCE (2010-2013)

  ◆ PROMOTION PATHWAY:➞ COUNSEL, USP LAW & PROMOTION COMPLIANCE (2009-2010)➞ ASSOCIATE COUNSEL, USP LAW & PROMOTION COMPLIANCE (2008-2009)➞ ASSOCIATE DIRECTOR, GLOBAL LABELING & PROMOTION COMPLIANCE (2007-2008)➞ MANAGER, GLOBAL LABELING & PROMOTION COMPLIANCE (2005-2007)◆ SCOPE: Earned numerous promotions for superior performance to Senior Counsel, spearheading all facets of regulatory/commercialization support for US, Middle East, and Africa marketing/sales and medical departments. Informed and advised clients on numerous issues, such as FDA and International Health Authority biopharmaceutical regulations, product development, foreign corrupt practices, False Claims Act, anti-kickback, labeling, adverting/promotion, compliance, and more.◆ ORGANIZATIONAL IMPACT:➲ Specifically selected to lead Law Department Diversity & Inclusion Committee.➲ Furnished key commercial regulatory and legal support for launch of multiple industry-leading products, such as Plavix, Eliquis, and Abilify.➲ Gained efficiencies with improved contracts and performing contracts training procedures.◆ ADDITIONAL EXPERIENCE:➞ IN-HOUSE COUNSEL – Manhattan Biopharm Consultants (2003-2005)➞ INTERN – Ortec International (2004)➞ SUMMER ASSOCIATE – Douglas & London (2002) Show less

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  Daiichi Sankyo

  Jan 2014 - Jan 2019

  ASSISTANT GENERAL COUNSEL, COMMERCIAL BRANDS

  ◆ SCOPE: Provided legal and commercial regulatory strategy and operational support for US and international clients of this innovative global healthcare company. Responsible for facilitating the development and commercialization of cardiovascular, pain, and oncology brands through alliances, collaborations, labeling, and product launches. Strategic business partner to the Marketing, Managed Markets, R&D, IT, Medical, Business Development, and Sales departments. Drafted and negotiated routine (MSAs, SOWs) and complex (collaborations, alliances) agreements and managed outside counsel. Legal department lead for the design, implementation, and improvement of processes and systems. Supervised attorneys and paralegals.◆ ORGANIZATIONAL IMPACT:➲ Demonstrated leadership in the establishment of multi-billion-dollar development and commercialization collaboration with AstraZeneca for Enhertu® ($10B forecasted peak annual sales).➲ Oversaw and delivered legal support for original buildout of commercial infrastructure, which enabled Daiichi Sankyo to transform from an organization focused on primary care to an industry-leading specialty oncology trailblazer and enter a $6.9B alliance with AstraZeneca.➲ Provided vital support for 3 co-promotion partnerships across oncology, cardiovascular, pain, and IDA.➲ Successfully managed high-value product liability and commercial litigation matters, protecting business interests within budget.➲ Investigated and resolved sensitive high-risk breaches of Corporate Code of Conduct.➲ Drafted and updated corporate Policies and SOPs and best practices.➲ 2015 Legal and Corporate Affairs Excellence Award recipient. Show less

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  Intercept Pharmaceuticals

  Jan 2019 - Jan 2023

  VICE PRESIDENT, (2021-2024)

  ➞ EXECUTIVE DIRECTOR (2019-2021)◆ SCOPE: Leader of domestic, and then global, legal activities supporting worldwide development and commercialization efforts for Intercept’s marketed and pipeline products. Supervised 7 attorneys and legal operations professionals in the US and Europe. Advise board and executives on product launches, compliance, public disclosure, and other business data. Coordinate outside counsel, manage $2.5M in budgets, and negotiate contracts.◆ ORGANIZATIONAL IMPACT:➲ Member, Senior Leadership Team, providing strategic legal advice on all areas of commercialization, transactions, compliance, HR.➲ Built, scaled, and managed legal and compliance teams (up to 7 FTEs) in North America and Europe; streamlined European department operations, enabling headcount reduction while maintaining high-touch support.➲ Oversaw legal and compliance and risk management for 30 countries accounting for $300M in annual sales.➲ Legal Representative, Executive Healthcare Compliance Committee, adapting the scope of the Compliance and Ethics program to align with OIG’s 7-points for an effective corporate compliance program business. ➲ Accelerated integration of $450M divestiture of Intercept ex-U.S. business to Advanz Pharma, enabling Intercept to sell the Company to Alfasigma S.p.A. for $19/share (89% premium).➲ Corporate Secretary for Pricing and Global Safety Committees; drafted formal Committee Charters, policies and procedures, and improved process for drafting, review and filing of materials and minutes, improving company records for business development opportunities and potential litigation.➲ Managed and rationalized annual budget of $2.5 million; reduced outside counsel costs by 20%.➲ Earned the 2023 Together for Tomorrow award, the top award in the company and the first and only time someone from Legal ever won. Show less

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  Intercept Pharmaceuticals

  Oct 2023 - now

  VICE PRESIDENT LEGAL AFFAIRS INTERCEPT (Nasdaq: ICPT) Acquired by Alfasigma 2023 - Consultant

  ◆ SCOPE: Consulting on the integration of Intercept as a wholly-owned subsidiary of Alfasigma S.p.A.

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  DGC HEALTHCARE ADVISORY SERVICES

  Mar 2024 - now

  Principal

  Consultant providing general counsel services to established and growing biopharma and life sciences companies on legal, compliance and business matters. Working with companies to: (1) support all aspects of preparing for and executing commercialization activities, (2) build and implement corporate compliance programs, (3) manage health authority filings and reviews to grow and manage pipelines and product franchises, (4) review and negotiate commercial transactions, (5) meet public disclosure obligations, (6) support Human Resources, (7) provide secretarial, governance and Board of Directors support. Show less