Sr. FDA Advisor

Job Locations US-VA-Arlington | US-NC-Cary HQ
Requisition ID
Travel Requirements

SAS is seeking a Sr. FDA Advisor with proven experience working in drug development, and possessing expertise surrounding the federal policy dynamics shaping clinical development and drug commercialization. Candidate must possess direct experience working with the Food and Drug Administration (FDA) – either within the Agency or in the commercial life sciences industry. This candidate will use their deep regulatory affairs and life sciences knowledge to advance SAS analytic solutions, deepen industry relationships and win new business opportunities.


Work location:  Prefer Washington, DC; open to Cary, NC applicants.


Primary Responsibilities:


Reporting to the Manager of Health Policy in U.S. Government, the candidate will provide executive leadership for SAS within the FDA and life sciences ecosystem. Responsibilities and functions include:


Knowing SAS

  • Learning current SAS products, practices, service offerings and resources that help position SAS within the FDA ecosystem and grow.

Planning and Supporting Sales Activities

  • Develop industry specific business development strategies that enables the SAS sales force to establish SAS as the preferred partner for key advanced analytic platform at the FDA. These strategies will need to address what solutions are best suited for current and future client needs.
  • Provide support and strategic guidance to SAS sales organization leadership to develop new account penetration strategies.
  • Assist with identifying additional business needs and sales opportunities to address what solutions are best suited for current and future client base
  • Articulate compelling SAS capabilities at the C-level and across organizational layers
  • Work with Federal lobbying infrastructure needs and identify any gaps in SAS’ existing offerings that need to facilitate SAS positioning
  • Identify competitive advances in the marketplace

Supporting and Growing Industry Relationships

  • Identify industry trends and sources of major disruption in the industry that well-position SAS and its offerings
  • Establish strategic vision and value propositions based on SAS offerings and the demand of the industry
  • Articulating compelling solution capabilities at the C-level within the FDA as well as with key Life Science clients
  • Establish relationships with customers including strategic high-level influencers, policymakers, decision-makers, operational management, and end users that establishes SAS as a credible and trusted advisor for informing current and future technology and analytic needs.
  • Provide support for corporate and sales goal attainment and strategic guidance on business plan development for SAS industry-focused account teams.
  • Identify, maintain and provide support and strategic guidance to the SAS sales organization leadership to develop new account penetration strategies
  • Identify competitor advances in the market
  • Provide support and be engaged in all states of sales engagement to foster current account relationships to drive greater business growth. 
  • Develop and maintain relationships with FDA and other key stakeholders to identify and develop effective strategic alignment of SAS solutions to their current and future needs. position.
  • Build customer references and support strategic opportunity growth through project expansion and identification of new sales opportunities.
  • Identify competitor advances in the market

Required Qualifications:

  • Bachelor's Degree, Master’s preferred, in Business, Business Marketing, Biology, Public Health, Biostatistics or related discipline
  • Require 8+ years of experience in the U.S. FDA and/or support organizations with hands on experience working on drug development, review and lifecycle management policy.
  • Require 8 (or more) years of experiencing in the U.S. Food and Drug Administration ecosystem Direct FDA experience is required.
  • Experience with drafting and implementing regulations and guidance at the federal level.
  • Proven ability to work collaboratively to facilitate business development strategies
  • Experience with drafting and implementing regulations and guidance at the federal level.
  • Knowledge of the life science regulatory industry, pharmaceutical companies, and/or Clinical Research Organizations [ the opening paragraph does not mention device companies – hard to get direct cross over here but most people could adapt to both in this situation]
  • Excellent communication skills and ability to work collaboratively in a dynamic team environment.


Additional skills:


  • Deep knowledge of current issues and trends with healthcare data integration and advanced analytics applications within industry, state and local government agencies.
  • Demonstrated experience in industry domain policies, procedures, relationships and credibility.
  • Demonstrated ability to present to all levels of an organization.
  • Excellent analytical and creative problem-solving skills.
  • Ability to work independently and as part of a team.
  • Excellent project management and facilitation skills.
  • Experience supporting sales across all stages of the customer lifecycle.
  • Ability to understand and translate complex technical and business information to non-technical internal/external audiences.





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