The Biotechnology Innovation Organization (BIO) is the premier biotechnology advocacy organization representing biotech companies, industry leaders, and state biotech associations in the United States and more than 35 countries around the globe. BIO members range from biotech start-ups to some of the world’s largest biopharmaceutical companies – all united by the same goal: to develop medical and scientific breakthroughs that prevent and fight disease, restore health, and improve patients’ lives. BIO also organizes the BIO International Convention and a series of annual conferences that drive partnerships, investment, and progress within the sector.

The Vice President, Senior Counsel will serve as a senior member of BIO’s legal team and as in-house legal counsel to BIO, with primary responsibility for FDA regulatory and health law matters. The role will advise on a range of legal and policy areas that are highly relevant to manufacturers of advanced biopharmaceutical products, including FDA law, market access, and public health (e.g., vaccine) policies.

The Vice President, Senior Counsel will collaborate closely with BIO member companies and other BIO staff to translate complex legal, policy, and scientific considerations into actionable policy positions. The Vice President, Senior Counsel will also support high-priority litigation efforts. As part of a collaborative legal team in an active trade association, the Senior Counsel will be responsible for advising, as needed, on the full range of legal and compliance issues relevant to a trade association, including, where necessary, through the efficient management of outside counsel resources. Recognizing the breadth of BIO’s policy and legal programs, candidates are not expected to have expert knowledge of all relevant areas of law but should have a robust foundation of expertise in at least one area, such as FDA law, and the curiosity to build new expertise quickly, including through the judicious use of outside counsel resources.

Primary Responsibilities

Support the development of BIO’s regulatory and health policy initiatives by providing expert legal analysis and advice of the highest quality across a range of issues.
Support BIO’s advocacy efforts at the federal, state, and international levels by analyzing proposed legislation, working with staff from BIO and BIO’s member companies to develop detailed policy positions, and communicating with policymakers at HHS, FDA, CMS, Congress, and other government agencies and legislative bodies.
Advise and provide support, as needed, on the full range of legal and compliance issues relevant to an active trade association, including through the efficient management of outside counsel resources where necessary.
Generate substantive work products, including policy papers, legal memos, comment letters, regulatory or legislative analyses, proposed regulatory or legislative language, and member updates.
Review and help develop briefs and other litigation documents and work with outside litigation counsel and BIO members, as appropriate, to develop and implement robust litigation strategies. Monitor external litigation.
Lead or support BIO committees, task forces, and working groups, including by planning and leading in-person or virtual working 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 coalition partners.

Qualifications

Education and Certifications

J.D. from an accredited law school.
Bar admission: DC Bar or eligibility to waive in.

Experience

7+ years of experience practicing law in a biopharma-related setting.
History of excelling in legal roles across multiple sectors (government, in-house, or law firm) preferred.
Scientific or technical background relevant to the life sciences preferred.

Knowledge, Skills, and Abilities (KSA’S)

Extensive expertise in one or more areas of health or biopharmaceutical regulatory law and policy, with the ability to rapidly develop expertise in additional areas as BIO’s priorities demand.
Expertise in administrative law and familiarity with litigation practice.
Strong interpersonal skills and a highly collaborative, team-oriented mindset will be critical to successful interactions with BIO staff, members, and other stakeholders.
Ability and commitment to exercise exceptional professional judgment at all times and provide high-quality advice to in-house clients at BIO across a range of areas, based on consultation with other experts when necessary.
Excellent skills in written and verbal advocacy, development of presentations on technical topics, and public speaking.
Ability to develop detailed and effective work plans 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 and solve problems creatively 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, including through careful management of committee or workgroup meetings.
Strong commitment to BIO’s mission and to working on behalf of BIO’s members with 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.

Physical Requirements

Sitting/Standing: Remaining in a stationary position for extended periods
Using Hands/Fingers: Operating a computer, keyboard, mouse, and other office equipment.
Vision: Close vision for computer work and detailed tasks.
Fine Motor Skills: Using a mouse, keyboard, and other small office tools.

Travel Requirements

Required travel: 10–20%, with concentrated travel expectations around the annual BIO convention and other key events

Work Environment

Hybrid: Monday and Friday virtual; Tuesday–Thursday in-office required

This job description is not intended to be all-inclusive, and responsibilities can be expected to evolve over time to meet changing business needs. The employee may be required to perform other related duties to meet these needs. While BIO’s intent is always to be clear and transparent about the expectations of this role, this job description may be reviewed and updated accordingly with or without notice. BIO is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity, or any other protected characteristic under federal, state, or local law. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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Vice President, Senior Counsel