Director, Regulatory Science and Policy

Director, Regulatory Science And Policy

The Director, Regulatory Science and Policy, works closely with the Vice President, Science Policy and Government Affairs (and Chief Policy Officer) to implement a wide range of exciting regulatory science and policy programs and activities related to the mission of the AACR. Such activities are designed to create and strengthen the dialogue between policymakers, cancer researchers, and advocates to educate policymakers and make substantive contributions to advance scientific opportunities, as well as work to suggest ways to help overcome policy barriers that are challenging cancer research and patient care. Many of the activities are guided and recommended by the AACR Science Policy and Government Affairs Committee (SPGA), as well as the Regulatory Science and Policy Subcommittee, which are AACR's principal means for devising strategies to influence important cancer-related and broader biomedical research-related policy issues, which are ultimately approved by the AACR Board of Directors on behalf of the collective membership of the AACR. Therefore, the Director, Regulatory Science and Policy plays a central role in guiding AACR policy activities to a productive conclusion, especially in areas that are focused on FDA-related issues.

The Director, Regulatory Science and Policy, monitors and provides background and analysis to AACR leadership on a wide variety of regulatory science and policy-related issues, such as: advancing personalized medicine, promoting innovative clinical trial designs, improving co-development of two or more novel drugs, informing regulatory science, and recommending ideas to include as part of the reauthorization of the FDA user fees for prescription drugs and medical devices.

The Director, Regulatory Science and Policy, will work with the entire team in the Office of Science Policy and Government Affairs, the CEO and AACR leadership, to develop and implement AACR-specific initiatives to further priority goals related to advancing cancer research and translating scientific discoveries into public health benefit, such as being called upon to support broader AACR initiatives to increase appropriations for cancer research and to develop content for briefings and other special sessions to educate Members of Congress and their staff about important pending legislation and issues affecting cancer research.

The Director, Regulatory Science and Policy, functions as a representative of the AACR when making key contacts with federal officials, congressional offices, survivor and patient advocacy organizations, and other relevant appropriate bodies. He/she helps to develop effective initiatives that encourage agency officials and members of Congress and their staff to consult the AACR and its expert members on important matters related to cancer and cancer research. Overall, the Director, Regulatory Science and Policy, under the direction of the Vice President, Science Policy and Government Affairs (and Chief Policy Officer), is responsible for developing and supporting AACR's expanding agenda in FDA-related regulatory science and policy areas.

The Director, Regulatory Science and Policy, will manage a team of employees, work on a number of regulatory-related policy issues, identify opportunities to disseminate the information to a broader audience, and collaborate with many of our external partners in the cancer research advocacy community.

Responsibilities

• Provide direction and support for AACR's science and health policy activities and priorities in terms of providing advice, establishing needs assessment, outlining strategies for implementation, and carrying them out to successful completion.
• Be proactive in identifying science policy and regulatory science and policy areas of importance and conduct policy analysis and development in relation to these issues.
• Support committee and task force activities, including coordinating meetings and providing background materials and draft reports.
• Work collaboratively with others in the AACR D.C. office, including the Chief Policy Officer and the Director, Government Affairs and Health Policy, particularly on the numerous policy issues that are crosscutting and currently being addressed by many of them.
• Monitor, analyze, and assess legislation as it pertains to priority science and regulatory science and policy issues.
• Prepare issue briefs and contribute policy articles for AACR's monthly policy newsletter and annual Cancer Progress Report to help inform AACR members, cancer organizations, targeted individuals, and other groups.
• Help shape special sessions and briefings to educate Members of Congress and their staffs about important pending legislation and issues affecting cancer research.
• Keep abreast of the scientific programs of the AACR and consider policy implications where appropriate.
• Develop and maintain strong working relationships with the policy staffs of other relevant organizations and coalitions.
• Establish relationships and collaborate with other AACR staff members who work in program development, communications and public relations, patient advocacy support, such as on the scientist-survivor program, and with the AACR Journal Cancer Discovery.
• Attend and report on relevant scientific and science and health policy meetings and conferences.
• Manage direct reports to achieve AACR's science and health policy goals.

Qualifications

• PhD, M.D., or other doctoral degree in a science and/or regulatory science-related field required.
• Ten (10) years of relevant experience in a science policy and/or regulatory science and policy-related environment.
• An expertise and a working knowledge and keen understanding of cancer research and biomedical related science, as well as an expert understanding of various areas of science policy and regulatory science and policy.
• Proven accomplishments in implementing complex policy projects.
• Superb written and oral communication skills.
• Excellent interpersonal skills.
• High degree of judgment and insight.
• A self-starter with creativity and initiative.
• Demonstrated problem-solving and decision-making abilities.
• Knowledge of government policies and procedures and the political process.
• Strong strategic thinker and someone who has shown an ability to carry through to completion an initiative and/or project.
• A demonstrated ability to analyze complex political and policy issues, build evidence based arguments for policy proposals to AACR approval bodies, and bring conflicting points of view to consensus.
• Ability to interact, negotiate, and work with VIPs and all levels of management on complex policy matters, including the CEO, Board members, relevant committee members, prominent scientists, Administration and Congressional officials, corporate executives, and members of the media.
• Ability to make rational decisions about achievable recommendations based on consideration of all facts and alternatives.
• Ability to work independently towards approved goals and objectives, while at the same time being able to predict when such approaches need discussion with AACR officials prior to final action.
• Ability to multi-task and work under rapidly developing deadlines and priorities.
• Ability to effectively communicate the progress and future needs of cancer research to various constituencies.
• Ability to effectively manage direct reports.
• PC, word processing, spreadsheet, and database programs.

American Association for Cancer Research