Senior Director, U.S. Regulatory Policy & Intelligence

POSITION SUMMARY:

Reporting to the Vice President of Global Regulatory Strategy, the Senior Director of U.S. Regulatory Policy & Intelligence provides leadership and strategic direction to the US Regulatory Policy and Intelligence function at Vertex. A member of the Regulatory Affairs Leadership Team, he/she will work with the Disease Area Heads and other internal colleagues to identify and address policy needs for our pipeline. He/she will also provide key insights to ensure that product strategies are informed and optimized to enable rapid development in the evolving regulatory environment. As Vertex’s pipeline continues to grow, this position will need to respond to the changing needs of the products, and span across modalities (small molecule, gene editing, gene therapy, biologics) and medical product types (including device and diagnostics).

Additionally, the Senior Director of US Regulatory Policy and Intelligence will be responsible for leading regulatory intelligence activities, anticipating, identifying, and communicating US regulatory policy issues/trends/changes occurring in the regulated environment that have the potential to impact our products. He/She will be responsible for partnering with internal stakeholders to respond to developments, both independently and through external stakeholders, and work to shape the regulatory environment to advance Vertex’s policy goals.

In addition to building and maintaining strong internal relationships across Global Regulatory Affairs, Global Medicines Development and Affairs, Research, and other key functions, the Senior Director of U.S. Regulatory Policy and Intelligence will also need to maintain a deep external network across stakeholders. This position will be responsible for representing Vertex externally within relevant and high-value multi-stakeholder regulatory forums, such as trade associations, and for internal communication and coordination regarding pertinent developments and opportunities, such as Agency communications and engagements. Established credibility amongst regulatory stakeholders, including FDA, is essential.

KEY RESPONSBILITIES:

• Develop and execute strategies to advance Vertex’s regulatory policy strategies to address specific pipeline needs.
• Collaborate with Global Regulatory Affairs leadership to create and implement a strategic plan for external stakeholder engagement on key policy priorities.
• Actively monitor the regulatory landscape to anticipate, identify, and communicate trends and developments that could impact Vertex and our pipeline of transformative medicines.
• Communicate in a timely manner regulatory developments, insights, and intelligence to Global Regulatory Affairs and other internal stakeholders, including other global functions and senior leadership.
• Represent Vertex Global Regulatory Affairs in multi-stakeholder forums including but not limited to: trade associations committees (e.g., BIO), professional associations, workshops, and other high-value opportunities for scientific and regulatory exchange, and ensure such opportunities are maximized by productive and concrete engagement
• Provide thought leadership in US regulatory policy and maintain/develop relationships with key leadership at Health Authorities and other external stakeholders.
• In partnership with relevant internal functions, lead the creation of Vertex’s responses to regulatory proposals put forward by formal regulatory bodies (e.g., FDA guidance) that are pertinent to our business and products
• Assist in preparing for meetings and interactions with FDA to discuss regulatory science topics
• Collaborate and communicate with Vertex global regulatory policy/intelligence colleagues across Vertex regions when appropriate (e.g., common issues for EMA, HC; comments on ICH guidelines)

COMPETENCIES AND SKILLS:

• Ability to work in an intense, fast-paced, innovative work environment
• Ability to work effectively as part of a global organization with internal executives and subject matter experts as well as with external stakeholders such as government officials and trade-association executives.
• Ability to lead across functions and drive to common goal
• High degree of individual initiative/drive yet team affinity
• Strong verbal/written skills

MINIMUM QUALIFICATIONS:

• Experienced Regulatory Professional with a degree in a scientific discipline such as pharmacy or a biological science, a law degree, or equivalent experience; higher degree preferred.
• Recognized expertise in regulations, guidelines and precedents related to pharmaceutical development for innovative small molecules and biologics; device expertise not necessary, but preferred.
• In-depth understanding of biopharmaceutical R&D lifecycle, and broad, comprehensive knowledge of the functions within a biotechnology company, and how they contribute to advancing product development and achieving corporate goals.
• Deep understanding of the pharmaceutical industry, particularly of R&D, Commercialization and Operations, and the global context in which the industry operates.
• Demonstrated ability to proactively shape regulatory frameworks and approaches through active membership in professional societies or trade organizations.
• Skilled communicator and facilitator with the demonstrated ability to represent Vertex as the Company’s lead liaison in opening doors for communications; a bridge-builder.
• Deep understanding of the political environment and culture within the FDA and the ability to identify key players to be engaged.
• Experience interacting with senior FDA members at Divisional and policy levels; high level of credibility and respect.