Position Title: Director, Infectious Disease Policy
Department: Policy Department
Reports to: Vice President, Infectious Diseases and Emerging Science
Compensation: Commensurate with experience, knowledge, and skills
Primary Purpose of the Position:
This position will lead the association’s policy and advocacy efforts related to antimicrobial resistance (AMR) and vaccine regulatory policy. It will also manage advocacy efforts related to immunization, working with member companies to develop and shape legislative and policy initiatives impacting vaccines, antimicrobials, and novel modalities to treat/prevent bacterial and fungal infections, and to demonstrate and promote the value of vaccines and biotechnology.
Essential Job Duties and Responsibilities:
- Lead BIO’s Antimicrobial Resistance (AMR) Policy Working Group, comprised of staff from over 50 member companies investing in a range of novel products (e.g. vaccines, antibiotics, monoclonal antibodies, microbiome therapies).
- Lead BIO’s efforts to coordinate and ensure alignment on AMR policy positions and advocacy strategies, including working with domestic AMR stakeholders (e.g. medical, patient, and civil society organizations) as well as international AMR stakeholders (e.g. International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the AMR Industry Alliance, the AMR Action Fund, the World Health Organization).
- Monitor, analyze, summarize, and respond to federal legislation and regulation that affects the discovery, development, commercialization and availability of novel vaccines and products to combat AMR. For example:
- Drafting technical comments to rules, regulations and other notices promulgated by the Department of Health and Human Services, including the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), the Centers for Disease Control and Prevention (CDC), the Biomedical Advanced Development and Research Authority (BARDA) and other relevant federal agencies.
- Drafting advocacy documents and legislative summaries for use with various internal and external audiences and stakeholders.
- Lead the development of BIO vaccines regulatory policy and advocacy priorities by managing the Vaccines Regulatory Affairs Committee (VacRAC), coordinating with the BIO Science and Regulatory team, interfacing with the FDA’s Center for Biologics Evaluation and Research (CBER) and coordinating with IFPMA on international vaccine regulatory issues, as appropriate.
- Represent BIO at meetings with government officials and stakeholders as a subject matter expert and industry spokesperson on issues related to vaccines and AMR, including accompanying lobbying staff to meetings with Congressional offices and making presentations at public meetings and conferences.
- Monitor, analyze and summarize federal legislation and regulation that affects vaccine development.
- Work cross-functionally within BIO, ensure coordination and communication across teams on policy development and advocacy strategy, particularly with the Health Section, the Federal and State Government Relations team, the Legal Department, the International team, and the Communications Department.
- Develop and maintain relationships with key U.S. regulatory agencies (e.g. FDA, CDC, NIH, BARDA, CMS, GAO, HRSA, FDA, State, and Commerce) as well as with the policy/regulatory staff in member companies, other trade associations, and stakeholder groups.
- Respond to BIO member company questions regarding AMR and vaccine reimbursement and regulatory policy issues.
- Respond to inquiries from the press as required, working through BIO’s Communications Department.
- Manage team requests on research for emerging issues and direct, as requested, any policy analysis that supports BIO policy development.
Knowledge and Skills Required:
- Excellent communication skills with the ability to provide timely and succinct analyses of technical policies in written and oral formats, as well as the ability to write both technical comments and advocacy papers.
- Excellent research (i.e., literature and secondary research) and analytical skills.
- Demonstrated ability to identify and prioritize tasks, manage staff as well as projects and meet deadlines with little supervision.
- Excellent organizational, consensus-building, and conflict management skills.
- Advanced level of understanding of Microsoft Office, including PowerPoint, and Word formatting and graphics, and Excel spreadsheet programming.
Education and Experience Required:
- Experience writing in numerous formats including presentations, advocacy documents and reports.
- Bachelor’s degree required with a graduate degree in relevant field (e.g. MPH, MPP, JD, MBA, PhD) preferred. Individuals with scientific or health policy backgrounds desirable.
- Must have direct experience in policy or business environment related to either AMR or vaccine issues, with 5+ years strongly preferred.
- Familiarity with the legislative and regulatory process strongly preferred.