Pharmaceutical Research and Manufacturers of America (PhRMA) is seeking an Associate Vice President for the Science and Regulatory Advocacy team to lead its advocacy activities related to biologics and biosimilars, and the implementation of the Biosimilars User Fee Act (BsUFA II).
The individual will report to the Deputy Vice President, Science and Regulatory Advocacy and work with colleagues across the organization to develop, evaluate and execute biologics and biosimilars advocacy priorities in the US and select international priority markets.
The Associate Vice President is responsible for:
- Developing and implementing a proactive strategy to increase awareness of the innovative biopharmaceutical industry's contribution to biologic and biosimilar medicines.
- Leading the development of PhRMA biologics and biosimilars policy and advocacy positions on US and international regulatory pathways, patents/data exclusivity, access (including payment and reimbursement policies), and user fee agreements in close coordination with relevant PhRMA departments and member companies.
- Support federal biologics and biosimilars advocacy priorities as well as represent industry externally, including advocating on behalf of the industry with third parties, Congress, and federal and international agencies.
- Managing the relationship and administration of relevant standing and ad hoc committees and working groups and the development and execution of strategic projects and initiatives for biologics and biosimilars advocacy, and the implementation of the Biosimilars User Fee Act (BsUFA II). Activities to include performing background research, creating project plans, managing deliverables, executing initiatives, soliciting member company input, as well as actively guiding cross-functional discussions within PhRMA and with PhRMA member companies, external stakeholders, and US and international science and regulatory bodies.
- Developing and presenting project proposals and outputs to PhRMA leadership and leadership committees.
- Serving as a credible and compelling subject matter expert both internally and externally for all biosimilars-related policy issues relevant to establishing a robust marketplace for safe and effective biosimilar products.
- Actively managing SRA activities including the facilitation of team work within the department and PhRMA-wide.
- Develop and manage budget and teams for projects as well as manage various third-party contractors.
Key Success Factors
PhRMA seeks a proactive, solutions-oriented, collaborator 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 as well as the ability to work independently. The preferred candidate will have a background in Biosimilars and/or Biologics and have a strategic mindset. S/he should be flexible, diplomatic, and have excellent communication skills including the ability to convey complex information in an audience-appropriate and compelling manner. Demonstrated consensus building, decision-making and interpersonal skills are essential. This is a highly 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, responsive, and mature.
Professional Experience / Requirements
- Bachelor’s degree (PhD, J.D. or other advanced degree preferred);
- 7+ years of relevant experience in drug discovery, development or regulatory advocacy, or related disciplines;
- 8+ years related work experience;
- Knowledge of drug discovery, development and related FDA regulations;
- Experience in biosimilars preferred;
- Strong negotiating skills/ability to influence and build consensus;
- Experience advocating publically on behalf of high-profile organizations in continuous settings;
- The ability to synthesize, distill, and communicate complex issues and ideas to a non-technical audience;
- 3+ years of relevant experience recommending strategies and policy in biologics and advocacy experience required;
- Experience with US or international biosimilars legal and regulatory frameworks a plus;
- Strong research and writing skills and the ability to synthesize, distill, and communicate complex ideas to a non-technical audienceStrong project management experience and ability to handle multiple strategic level projects;
- Strong analytical and strategic planning skills;
- Excellent communication skills required: verbal, written, listening and presentation.
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. Since 2000, PhRMA member companies have invested more than half a trillion dollars in the search for new treatments and cures, including an estimated $58.8 billion in 2015 alone.
Connect with PhRMA
For information on how innovative medicines save lives, please visit:
What we offer
In addition to a highly competitive salary, generous 401(k) employer contribution 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, health advocate service, back-up childcare, commuting and financial & estate planning benefits.
Certified as a CEO Cancer Gold Standard employer by the CEO Roundtable and having been named one of Washington’s Healthiest Employers, PhRMA provides a fitness subsidy, on-site fitness facility and fitness classes, an annual health fair and extensive employee wellness seminars, events and challenges.
We are committed to the growth and development of our team members and offer many learning opportunities such as tuition reimbursement at both the undergraduate and graduate levels, industry on-site and off-site training, PhRMAcademy lunch and learn sessions, presentation skills, performance management and other management/professional develop programs. Corporate social responsibility is also important to us at PhRMA. Our team members participate in organization-wide community service activities 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 own 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 non-discrimination in employment.
Send resume, cover letter and salary requirement for consideration to: firstname.lastname@example.org.