Senior Director – Science and Regulatory Advocacy

  • PhRMA
  • Washington, DC, USA
  • Apr 20, 2020
Full time Government Health Care Pharmaceutical

Job Description

Pharmaceutical Research and Manufacturers of America (PhRMA) is seeking a Senior Director for the Science and Regulatory Advocacy (SRA) team to support its domestic regulatory policy and advocacy efforts. The Senior Director, SRA, will work under the direction of the Deputy Vice President and will serve as the SRA lead executing key science and regulatory activities related to domestic regulatory policy and advocacy, including efforts related to the Prescription Drug User Fee Act (PDUFA) implementation.

 

The Senior Director is responsible for:

  • Supporting 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.
  • Managing the development and execution of projects and initiatives related to science and regulatory advocacy efforts (e.g., soliciting member company input, actively guiding cross-functional discussions and consensus-building within PhRMA and PhRMA member companies, engaging external stakeholders, creating project plans, and executing initiatives). Working as a portfolio manager, manage and coordinate SRA work groups to ensure portfolio activities are aligned with SRA’s consensus scientific and regulatory policy positions.
  • Developing and presenting project proposals and outputs to SRA leadership and leadership committees; supporting integration and coordination of domestic regulatory policy priorities inside and outside of SRA.
  • Acting as a primary point of contact for internal and external stakeholders on select SRA portfolio topics.
  • Developing and maintaining collaborative relationships with key external stakeholders such as regulatory bodies (e.g., FDA), sister industry associations (e.g., BIO), and other relevant third-party stakeholders.

 

Key Success Factors
PhRMA seeks a proactive, strategic thinking 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 drug discovery/development, regulatory affairs and advocacy 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 among internal and external stakeholders, 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, and responsive.  

 

Professional Experience / Requirements

  • Bachelor’s degree
  • A minimum of 5+ years of relevant experience in drug discovery, development or regulatory affairs;
  • Demonstrated knowledge of drug discovery, development and related FDA regulations;
  • Ability to inspire confidence within the organization and with external stakeholders;
  • Ability to synthesize various stakeholder perspectives and input into clear, consolidated advocacy positions;
  • Strong project management experience with the ability to handle multiple projects;
  • Strong analytical and strategic planning skills;
  • Excellent verbal, written, listening and presentation communication skills required;
  • Results-oriented team player;

 

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;
  • Biopharmaceutical industry, regulatory agency and/or trade association experience preferred with a keen understanding of organizational operations/dynamics.

 

Who we are
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovation 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 $900 billion in the search for new treatments and cures, including an estimated $79.6 billion in 2018 alone.

Connect with PhRMA
For information on how innovative medicines save lives, please visit:
www.PhRMA.org
www.Innovation.org

www.GoBoldly.com

www.Facebook.com/PhRMA
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, 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.