Vice President, Senior Counsel

Biotechnology Innovation Organization•Washington, DC

5d•Hybrid

About The Position

Biotechnology Innovation Organization (BIO) is the world’s largest advocacy association representing member companies, state biotechnology groups, academic and research institutions, and related organizations across the United States and in 30+ countries. BIO members are involved in the research and development of innovative healthcare products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investors and partnering meetings held around the world. The Vice President - Senior Counsel will serve as a senior member of BIO’s legal team, legal counsel to BIO with responsibility for intellectual property (IP) and FDA regulatory legal matters. The role will focus on legal and policy issues related to patents in the biotechnology sectors and on FDA regulatory areas, including Hatch-Waxman and biosimilar issues. The Senior Counsel will collaborate closely with BIO member companies and other BIO staff to translate complex legal and scientific considerations into actionable policy positions. As part of a collaborative legal team in an active trade association, the Vice President - Senior Counsel will also be responsible for advising, as needed, on the full range of legal and compliance issues relevant to a trade association, including through efficient management of outside counsel resources where necessary.

Requirements

J.D. from an accredited law school.
Bar admission: DC Bar or eligibility to waive in.
10+ years of biopharma-related legal experience; scientific/technical background preferred.
Expertise in IP law and FDA regulatory law, with the ability to rapidly develop expertise in additional areas where needed. Similarly, expertise in administrative law and familiarity with litigation practice will be critical.
Strong interpersonal skills, exceptional judgment, and a highly collaborative, team-oriented mindset will be critical to successful interactions with BIO staff, members, and other stakeholders.
Excellent skills in written and verbal advocacy, development of presentations on technical topics, and public speaking.
Ability to develop detailed and effective workplans and budgets for internal use or to manage external consultants or outside counsel.
Expert-level statutory/regulatory/policy analysis and strategy development. Ability to manage multiple complex workstreams simultaneously and to work efficiently under very tight deadlines.
Proven ability to translate complex legal/regulatory/technical/scientific issues into clear policy narratives.
Experience with coalition-building and multi-stakeholder coordination and the ability to drive consensus among different perspectives.
Commitment to BIO’s mission and member-driven service and to working at the highest level of professionalism and integrity
Ability to operate with a high degree of autonomy and minimal supervision.
Comfort engaging with senior executives, policymakers, and technical experts.
Strong organizational and project management skills.

Nice To Haves

History of excelling in legal roles across multiple sectors(government, in-house, or law firm) preferred.
scientific/technical background preferred.

Responsibilities

Lead the development of BIO's IP policy initiatives, in collaboration with BIO members, providing expertise in biopharma patent law and policy, including USPTO-related policies and procedures.
Provide advice and Support to BIO’s Science and Regulatory Center of Excellence including through advising on materials related to regulatory- issues, positions and related advocacy.
Provide cross-cutting advice to BIO on patent-and FDA-related law and policy. While IP-related areas will be a primary focus, including patent law, Hatch-Waxman, and biosimilar issues, the Senior Counsel will be also responsible for advising on the full range of FDA law relating to the regulation of drugs and biologics.
Support BIO’s advocacy efforts on IP- and FDA-related areas, including through interaction with policymakers at USPTO, FDA, and other public sector and non-governmental entities at the federal, state, and international level.
Advise as needed on the full range of legal and compliance issues relevant to a trade association, including through efficient management of outside counsel resources where necessary.
Generate high-impact work products, including policy papers, comment letters/agency submissions, legislative analyses or proposed legislative language, and member updates.
Monitor relevant IP and FDA litigation and develop BIO litigation strategy on IP and FDA issues, including through the development of amicus briefs and coordination with BIO members.
Provide advice and support to BIO’s National Security and International Affairs Center of Excellence, including through advising on or developing advocacy materials related trade-related issues, international agreements, and regulatory harmonization.
Lead or support BIO Committees, Task Forces, and Working Groups, including by planning and leading working in-person or virtual sessions with members and other stakeholders.
Advance rigorous thought leadership through work with academic researchers and key opinion leaders and serve as a BIO liaison to external IP coalitions/trade groups.