Senior Director, Federal Government Affairs

Position Title: Senior Director, Federal Government Affairs

Department: Commercial

Reports To (title): Vice President, Market Access and Trade

Location: Remote – ideally based in Washington DC, Maryland or Virginia

Summary of Position:

The Senior Director, Federal Government Affairs will play a pivotal role in engaging with government stakeholders regarding future procurement opportunities related to Paratek Pharmaceutical's (Paratek) drug with an anticipated biothreat indication. The position requires a deep understanding of government processes, regulatory frameworks, and strategic engagement with key stakeholders to advance the company's interests. The successful candidate will be proactive, politically astute, and possess excellent communication skills to effectively navigate complex policy and regulatory landscapes. The primary responsibility of this role is to engage with the U.S. Government (USG) regarding an anticipated sNDA approval of NUZYRA® (omadacycline) for an anthrax indication. In addition, the Senior Director, Federal Government Affairs, will help Paratek evaluate and pursue opportunities for the purchase of NUZYRA for use with military personnel to treat wound infections. The ideal candidate has a strong background in government relations, excellent communication skills, and a proven track record of influencing policy decisions at the federal level.

Position Responsibilities:

Government Relations:

• Develop and maintain relationships with key government officials, including members of Congress, relevant committees, federal agencies, and other stakeholders.
• Develop and implement advocacy strategies to promote the inclusion of novel antibiotics for biothreats in government procurement requirements.
• Develop comprehensive briefing documents and engage directly with the USG to advocate for the establishment of requirements for purchasing (and stockpiling) novel antibiotics aimed at combating biothreats.
• Identify and pursue funding mechanisms from the USG to support the procurement (including stockpiling funding requirements) of novel antibiotics for combating biothreats.
• Collaborate with internal teams to gather data and evidence supporting the need for novel antibiotics in biosecurity initiatives.
• Monitor legislative and regulatory developments related to biosecurity, biodefense, and public health to identify opportunities and threats to the company's objectives.
• Represent the company's interests in relevant industry associations, coalitions, and working groups.
  
  

Advocacy and Lobbying:

• Develop and implement advocacy strategies to secure appropriations and procurements for NUZYRA® (omadacycline) with a biothreat indication.
• Draft persuasive communications, including briefing materials, position papers, and advocacy letters, to influence policymakers and stakeholders.
• Organize and participate in meetings, briefings, and events with policymakers to advocate for the company's priorities.
• Established passion for advancing public health initiatives.
  
  

Policy Analysis and Research:

• Conduct policy analysis and research on relevant legislative and regulatory issues impacting the pharmaceutical industry, biosecurity, and biodefense.
• Provide insights and recommendations to internal stakeholders on emerging policy trends, risks, and opportunities.
  
  

Compliance and Ethics:

• Ensure compliance with applicable laws, regulations, and industry codes of conduct related to lobbying and government relations activities.
• Uphold the highest ethical standards in all interactions with government officials and stakeholders.
  
  

Lobbyist Registration and Compliance:

• Ensure timely and accurate registration as a lobbyist with the appropriate federal authorities.
• Maintain full compliance with all federal laws and regulations governing lobbying activities, including the Lobbying Disclosure Act (LDA) and any applicable ethical guidelines.
• Prepare and submit all required lobbying reports and disclosures, detailing activities, expenditures, and contributions, in a timely manner.
• Uphold the highest ethical standards in all interactions with government officials and stakeholders.
• Stay informed about changes in lobbying laws and regulations and participate in regular training and education on compliance requirements.
  
  

Candidate Requirements:

• Emulates Paratek's Core Values: Resourceful, Collaborative, Passionate, Purposeful
• Bachelor's degree in political science, public policy, law, or a related field. Advanced degree preferred.
• 10+ years of experience in government affairs, public policy, or related roles, preferably within the pharmaceutical or healthcare industry.
• Demonstrated history of successfully securing federal contracts and/or appropriations for funded procurements.
• Demonstrated knowledge of federal legislative and regulatory processes, particularly in the areas of appropriations and procurement.
• Demonstrated knowledge of federal funding mechanisms, grant-making processes, and contracting procedures, particularly within agencies such as the Department of Health and Human Services (HHS), Department of Defense (DoD), and Biomedical Advanced Research and Development Authority (BARDA).
• Strong interpersonal skills with the ability to build relationships and influence decision-makers.
• Excellent written and verbal communication skills, with the ability to distill complex issues into clear and compelling messages.
• Excellent research, analytical, and problem-solving skills, with the ability to synthesize information from multiple sources and identify funding opportunities that align with organizational priorities.
• Ability to work independently, manage multiple priorities, and thrive in a fast-paced environment.
• Commitment to upholding ethical standards and maintaining confidentiality.
  
  

Additional Information:

• Technology needs: Microsoft Office (Word, Excel, PowerPoint, Outlook)
• Travel requirements (%): 30%