Pharmaceutical Research and Manufacturers of America (PhRMA) is seeking a Senior Director for the Science and Regulatory Advocacy (SRA) team to support its science and regulatory portfolio efforts related to drug development tools.
The individual will report to the Deputy Vice President of Science and Regulatory Advocacy and work with colleagues across the organization to provide strategic direction and guidance to PhRMA’s standing or ad hoc committees and expert working groups focused on drug development tools, including biomarkers and non-traditional sources of evidentiary data (e.g., real world evidence), as well as pre-clinical development. This includes ensuring the successful execution of drug development tools advocacy initiatives under the supervision of the Deputy Vice President.
The Senior Director is responsible for:
- Driving the development, evaluation, and execution of drug development tools advocacy priorities in the US, in close collaboration with SRA colleagues and other relevant PhRMA departments; and supporting the SRA international portfolio related to drug development tools by ensuring technical input and consistent messaging across US and international advocacy platforms (e.g., industry comments to draft FDA regulations/guidelines and ICH draft guidelines).
- Managing the relationship and administration of relevant standing and ad hoc committees and working groups, as well as the development and execution of strategic projects and initiatives related to drug development tools advocacy (e.g., performing background research and soliciting member company input, actively guiding cross-functional discussions within PhRMA and PhRMA member companies, engaging other external stakeholders, creating project plans, managing deliverables, and executing initiatives).
- Developing and presenting project proposals and outputs to SRA and PhRMA leadership and leadership committees; serving as a credible and compelling subject matter expert (point of contact), who can integrate the vision of drug development tools advocacy into SRA and PhRMA priorities.
Key Success Factors
PhRMA seeks a proactive, confident and action-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 collaborative focus. The preferred candidate will bring substantive drug development and regulatory affairs expertise and be an organized, detail-oriented, self-starter with excellent writing skills and the ability to convey content 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, diplomatic, responsive, and mature.
Professional Experience / Requirements
- Bachelor’s degree (PhD or Master’s degree in Health Science-related fields, Regulatory Affairs, Health Policy, or related field preferred);
- A minimum of 3 years of relevant experience in drug discovery, development or regulatory advocacy;
- 5+ years of related work experience including third-party stakeholder outreach and engagement, proven management of complex issues, projects, tasks, requests, and timelines;
- Knowledge of drug discovery, development and related FDA regulations;
- Strong project management experience and ability to handle multiple projects;
- Strong analytical and strategic planning skills;
- Excellent communication skills required: verbal, written, listening and presentation;
- Experience in drug development tools policy and advocacy, US drug development tools, or clinical development legal and regulatory frameworks;
- A results-oriented team player;
- Ability to inspire confidence within the organization and with external constituencies.
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: http://bit.ly/PHRMA-SRA-DDT.