Senior Director – Science and Regulatory Advocacy (Biosimilars and BsUFA Advocacy)
Senior Director – Science and Regulatory Advocacy
Pharmaceutical Research and Manufacturers of America (PhRMA) is seeking Senior Director for the Science and Regulatory Advocacy (SRA) team to lead its regulatory advocacy activities related to biosimilars and the Biosimilars User Fee Act (BsUFA).
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 biosimilars and BsUFA advocacy priorities in the US and select international priority markets.
The Senior Director is responsible for:
- Leading the development of PhRMA policy and regulatory advocacy positions on biosimilars and BsUFA in close coordination with relevant PhRMA departments and member companies.
- Executing and supporting on strategic projects and initiatives for biosimilars and BsUFA advocacy. Activities to include performing background research, creating project plans, managing deliverables, 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 (SRA) leadership and working groups.
- Serving as a credible and compelling subject matter expert both internally and externally for all biosimilars-related regulatory policy issues
- Actively managing SRA activities including the facilitation of teamwork within the department and PhRMA-wide.
- Developing, presenting, and implementing budget lines for projects as well as managing 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 preferably biologics along with 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;
- 4+ years of relevant experience in R&D, drug development or regulatory advocacy, or related disciplines;
- 6+ years related work experience;
- 3+ years of relevant experience recommending strategies and policy in biosimilars (strongly preferred) and advocacy experience required;
- Knowledge of drug discovery, development and related FDA regulations;
- Strong negotiating skills/ability to influence and build consensus;
- Experience advocating publicly on behalf of high-profile organizations;
- 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 and ability to handle multiple strategic level projects;
- Strong analytical and strategic planning skills;
- Excellent communication skills required: verbal, written, listening and presentation.
- PhD, J.D. or other advanced degree;
- Experience with US and/or international biosimilars legal and regulatory frameworks;
- Experience with biologic products, including cell and gene therapy.
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 $600 billion in the search for new treatments and cures, including an estimated $71.4 billion in 2017 alone.
Connect with PhRMA
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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, 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 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.