Location: Washington, DC
Date Posted: 11/02/2023
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 regulatory policy and advocacy efforts. The Director, SRA, will work under the direction of the Deputy Vice President and will serve as the SRA representative supporting key science and regulatory activities related to domestic regulatory policy and advocacy, such as efforts related to the Prescription Drug User Fee Act (PDUFA) implementation.
The Director will:
Assisting in driving the development, evaluation, and execution of select 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 science and regulatory advocacy efforts (e.g., soliciting member company input, preparing and submitting comment letters in response to regulatory guidance, actively guiding cross-functional discussions and consensus-building within PhRMA and PhRMA member companies, engaging external stakeholders, working towards project plans, and executing initiatives).
Coordinating select SRA work groups to ensure portfolio activities are aligned with SRA’s consensus scientific and regulatory policy and advocacy positions.
Developing and presenting select project proposals and outputs to SRA leadership and leadership committees; supporting the SRA team’s effort to integrate and coordinate domestic regulatory policy priorities. Will support international regulatory harmonization efforts, as needed.
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 (e.g., patient advocacy groups).
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
A minimum of 6 years of relevant experience in drug research & development and/or regulatory policy and advocacy.
Demonstrated knowledge of drug research & 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/Master’s degree in Pharmaceutical or Life Sciences, Chemistry, Medical Sciences, Public Health, Regulatory Sciences, Health Policy, or related disciplines.
Scientific, consulting, or advocacy/policy experience relevant to translational science, regulatory science, and/or preclinical and clinical research associated with medical product development.
Experience advocating publicly on behalf of high-profile organizations.
Biopharmaceutical industry, regulatory agency, and/or trade association experience preferred with a keen understanding of organizational operations/dynamics.
$107,300 to $140,125 per annum. Salary is commensurate with experience and other compensable factors.
Who We Are
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives. Over the last decade, PhRMA member companies have more than doubled their annual investment in the search for new treatments and cures, including nearly $101 billion in 2022 alone.
Connect with PhRMA
For information on how innovative medicines save lives, please visit:
In addition to a highly competitive salary and bonus program, various opportunities for reward and recognition and a platform of extensive benefits, PhRMA is committed to the development and overall wellbeing of our team members. We offer traditional (medical, dental, vision, flexible spending, life, AD&D, LTD, STD, LTC) and enhanced benefits such as parental leave, a wellbeing program, back-up care, health advocate service, employee assistance program, and commuting benefits. We also offer a robust 401k plan with employer contributions upon the first day of hire and immediate vesting, a generous paid time off plan, seven paid holidays (plus inauguration day), half day Fridays preceding holidays, and a paid winter break.
We are committed to the growth and development of our team members and offer many learning opportunities including an integrated on-boarding program, best-in-class leadership programming, tuition reimbursement at both the undergraduate and graduate levels, industry on-site and off-site training, and other management/professional development programs. Corporate social responsibility is also important to us at PhRMA. Our team members participate in organization-wide community service activities, fundraising drives, and charitable athletic events.
Equal Opportunity Employer
PhRMA provides equal employment opportunities to all applicants without regard to race, color, religion, national origin, sex, age, marital status, personal appearance, sexual orientation, gender identity or expression, family responsibilities, genetic information, disability, matriculation, political affiliation, or veteran status in accordance with applicable federal, state, and local laws governing non-discrimination in employment.