Position Title: Vice President, Science and Regulatory Affairs
Department: Science and Regulatory
Reports to: Chief Scientific Officer
Primary Purpose of the Position:
The Vice President, Science and Regulatory Affairs, has lead responsibility for policy development and successful execution of initiatives that improve the ability of BIO companies to conduct research and development and gain regulatory approval of products, both within the United States and internationally. The focus of the position will be primarily on Food and Drug Administration and NIH policies and activities, but will also include advocacy with numerous scientific, regulatory and other bodies both in the United States and abroad.
The Vice President manages the BIO Board Regulatory Environment Committee (REC) and all staff-level Science and Regulatory Committees. The Vice President reports the Chief Scientific Officer and works with other departments within BIO to develop and implement strategic BIO positions and responses to key healthcare regulatory and legislative issues identified by the BIO Board. The Vice President manages BIO’s science and regulatory staff and is charged with developing BIO’s regulatory policy agenda and implementation strategies related to the drug and biologic discovery, development, and approval processes; passage and implementation of FDA-related legislation; and science and policy issues at all health agencies, including the National Institutes of Health (NIH).
- Build and lead a strong science and regulatory advocacy function for BIO
- Ensure that BIO identifies current and future scientific and regulatory developments, is fully prepared to engage in advocacy relating to these developments as and when appropriate, and achieves the Board-approved goals for scientific and regulatory affairs.
- Engage company staff, at both the Board and non-Board level, to ensure they provide input to and ultimately support BIO advocacy activities.
- Manage and direct Science and Regulatory staff as they carry out specific activities to develop and achieve advocacy goals.
- Track the development of guidance documents, regulations, and other regulatory initiatives in areas of interest to our companies and seek opportunities for BIO input. Coordinate the development and approval of written responses to the docket, and verbally communicate BIO positions to relevant government officials.
- Represent BIO externally as BIO’s lead science and regulatory executive for health biotech issues. Represent and advocate for BIO at key meetings and with key audiences, which may include the BIO Board of Directors and their lead staff, legislative and executive branch officials, other industry groups, the media, academia, patient advocates, and the public at large.
- Lead and manage the planning and hosting of dialog sessions with regulatory agencies on behalf of BIO companies. Maintain and develop new, constructive relationships with potential allies and with pertinent government officials.
- Provide counsel and serve as a resource within BIO on science and regulatory issues. Advise the Executive and senior BIO staff on regulatory policies and BIO’s policy agenda.
- Ensure that Science and Regulatory staff work collaboratively with other BIO staff, in particular with Government Relations and Legal, to help ensure achievement of BIO’s legislative goals, and with Communications to support BIO advocacy generally and to communicate the promise of the science of health biotechnology.
- Work with other departments at BIO to translate scientific and regulatory issues into language suitable for background and advocacy documents, especially for audiences with no scientific background.
- Help organize Science and Regulatory tracks at BIO Annual Meeting.
- Work with staff to develop performance goals and objectives that integrate with and lead to successful achievement of the Health Section workplan goals; evaluate staff performance on a regular basis; and manage effectively and efficiently BIO resources. Ensure that staff motivation and performance is high by helping to develop challenging and interesting assignments that suit the particular interests and professional goals of staff and also promote execution of BIO and Health Section goals.
Knowledge and Skills Required:
- In depth understanding of the regulatory and legislative process, and specific experience and understanding of FDA regulations as well as the drug approval process.
- Solid understanding of the international policy and regulatory environment
- Solid scientific understanding of biotechnology
- Proven ability and reputation for conceptual thinking
- Superb communication skills, verbal and written, including public speaking skills
- Thorough understanding of committee management, including consensus-building skills
- Highly driven, conscientious and results-oriented, but also pragmatic and flexible
- Ability to work as part of a team, but balanced by independence, confidence and initiative
- Willingness to travel as needed.
Education and Experience Required:
- Master’s Degree, PhD or MD in relevant area of study strongly preferred, or equivalent work experience in relevant field required.
- 12 or more years of policy experience with the biotechnology industry, private or non-profit health policy advocacy organization, Congressional Committee staff or a government agency (FDA or NIH)
- Extensive understanding of the regulatory and legislative process, and specific experience and understanding of FDA regulations and drug approval processes.
- Prior work experience within a government regulatory agency, ideally the FDA, a plus.