Director, Science and Regulatory Advocacy at PHRMA

Washington, District of Columbia, United States -

Full Time

Start Date

Immediate

Expiry Date

28 Aug, 26

Salary

151900.0

Posted On

30 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Advocacy, Drug Development, Consensus Building, Project Management, Strategic Planning, Stakeholder Engagement, Technical Writing, Public Speaking, FDA Regulations, Clinical Research, Policy Analysis, Digital Health Technologies, Real-World Evidence, Interpersonal Skills, Diplomacy, Analytical Skills

Industry

Pharmaceutical Manufacturing

Description

Overview 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. Who we are The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are laser focused on developing innovative medicines that transform lives and create a healthier world. Together, we are fighting for solutions to ensure patients can access and afford medicines that prevent, treat and cure disease. Over the last decade, PhRMA member companies have invested more than $850 billion in the search for new treatments and cures over the last decade, supporting nearly five million jobs in the United States. Connect with PhRMA For information on how innovative medicines save lives, please visit: www.PhRMA.org [http://www.phrma.org/] www.Innovation.org [http://www.innovation.org/] www.MAT.org [http://www.mat.org/] www.Facebook.com/PhRMA [http://www.facebook.com/PhRMA] www.Twitter.com/PhRMA [http://www.twitter.com/PhRMA] What we offer 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 and STD) and enhanced benefits such as parental leave, a well-being program, on-site fitness facility, back-up care, an employee assistance program, and pre-tax 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, -ten paid holidays (plus inauguration day), half day Fridays preceding holidays, half day Fridays in the summer months and a paid winter break. As an organization, we work remotely on Mondays and Fridays and together in the office on Tuesdays through Thursdays. We also all work remotely in the month of August. We are committed to the growth and development of our team members and offer many learning opportunities including an integrated onboarding program, best-in-class leadership programming, tuition reimbursement, 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 community service activities, fundraising drives and charitable athletic events. We are committed to supporting our family of professionals at PhRMA and strive to create programs that help our team members manage the challenges of balancing a fast-paced career with their personal goals. 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 nondiscrimination in employment. The job description contains an overview of the activities and duties for this role. Responsibilities may change and new ones may be assigned at any time.

Responsibilities

Lead domestic and international science and regulatory advocacy efforts, focusing on digital health, AI, and real-world evidence. Coordinate with member companies and regulatory bodies like the FDA to develop and execute policy priorities.