Director, Science and Regulatory Advocacy

Director Science And Regulatory Advocacy

Pharmaceutical Research and Manufacturers of America (PhRMA) is seeking a Director for the Science and Regulatory Advocacy (SRA) team to support its domestic and international regulatory policy and advocacy efforts. The Director, SRA, will work under the direction of the Deputy Vice President and will serve as the SRA lead executing key activities related to domestic and international policy and advocacy, such as efforts related to digital health technologies, including AI, regulatory IT/cloud, and related data use, including real-world data/real-world evidence.

The Director is responsible for:

• Assisting in driving the development, evaluation, and execution of science and regulatory advocacy priorities in the US, in close collaboration with SRA colleagues and other relevant PhRMA departments.
• Supporting the development and execution of projects and initiatives related to these science and regulatory advocacy efforts (e.g., soliciting input from member companies, preparing and submitting comment letters in response to regulatory guidance, actively guiding cross-functional discussions and consensus-building within PhRMA and among PhRMA member companies, engaging external stakeholders, creating project plans, and executing initiatives).
• Coordinating select SRA Work Groups to ensure that portfolio activities align with PhRMA's consensus scientific and regulatory policy positions.
• Developing and presenting project proposals and outputs to SRA leadership and leadership committees; supporting the SRA team's effort to integrate and coordinate domestic regulatory policy priorities internally and externally, including supporting international harmonization efforts, as applicable.
• Serving as a point of contact for internal and external stakeholders on select SRA portfolio topics. Speaking authoritatively on specific areas of subject matter expertise, both internally and externally, for select regulatory policy issues.
• Developing and maintaining collaborative, productive relationships with key external stakeholders such as regulatory bodies (e.g., FDA), sister industry associations (e.g., BIO), and other relevant third-party stakeholders.
• Performing other duties as assigned.

Key Success Factors PhRMA seeks a proactive, solutions-oriented, individual who is passionate about contributing to the health care challenges we face today. Key success factors for this role include a strong sense of team and a collaborative focus, as well as the ability to work independently.

The preferred candidate will have a background in drug development, regulatory affairs and advocacy expertise, along with a creative mindset, and be an organized, detail-oriented self-starter with excellent communication skills and the ability to convey complex content in an audience-appropriate and compelling manner. Demonstrated consensus building among internal and external stakeholders and interpersonal skills are essential. This is a visible, fast-paced position that is both internally and externally facing. Accordingly, the successful candidate should be adaptable, able to reprioritize and shift gears quickly, comfortable in a high-pressure environment and be politically savvy, diplomatic, and responsive.

Professional Experience / Requirements

• Master's degree in Pharmaceutical or Life Sciences, Medical Sciences, Public Health, Translational Sciences, Health Policy or related disciplines or MPH.
• 6+ years of relevant experience in drug discovery, development or related role.
• Demonstrated knowledge of drug research and development and related FDA regulations.
• Ability to inspire confidence within the organization and with external stakeholders.
• Ability to influence and build consensus.
• Strong research and writing skills and the ability to synthesize, distill, and communicate complex issues and ideas to a non-technical audience.
• Strong project management experience with the ability to handle multiple projects.
• Strong analytical and strategic planning skills.
• Excellent communication skills required: verbal, written, listening and presentation.

Preferred Experience / Requirements

• PhD or other advanced degree (e.g., PharmD) in Pharmaceutical or Life Sciences, Medical Sciences, Public Health, Translational Sciences, Health Policy or related disciplines;
• Scientific, consulting or advocacy/policy experience relevant to clinical science, regulatory science, and/or clinical research associated with medical product R&D and clinical trials;
• Experience advocating publicly on behalf of high-profile organizations; and
• Biopharmaceutical industry, regulatory agency, and/or trade association experience preferred with a keen understanding of organizational operations/dynamics

Potential Salary

$110,500-151,900 per annum. Salary is commensurate with experience and other compensable factors.