Director, Regulatory Science and Policy

Overview:
Under the leadership of the AACR Chief Policy Officer/Vice President, Science Policy and Government Affairs, the Director, Regulatory Science and Policy will provide expertise and support to AACR leaders, the Science Policy and Government Affairs Committee and its Regulatory Science and Policy Subcommittee, and the broader advocacy community on regulatory science and policy-related issues and cross-cutting activities to further the goals of the AACRs Strategic Plan and policy priorities.The Director, Regulatory Science and Policy will manage a team of staff members and play a central role in the success of the AACRs work in this important area. He/she willguide the AACRs regulatory science and policy programs and activities and bring them to a productive conclusion. Such activities are designed to create and strengthen the dialogue among policymakers on Capitol Hill and at the FDA, scientists, and advocates, as well as to provide expert support to policies that advance safe and effective therapies for patients with cancer, including those in support of our mission: to prevent and cure cancer through research, education, communication, collaboration, science policy and advocacy, and funding for cancer research.This professional will provide expertise on regulatory science and policy issues that are important to the AACR and the cancer field. He/she will demonstrate innovation, takeinitiative in the development and execution of projects, and oversee project management, committee support, and consensus building among stakeholders. Responsibilities include monitoring, researching, and analyzing regulatory science and policy initiatives in AACR priority areas; developing policy statements; compiling background information; attending and summarizing the proceedings of relevant meetings and events; serving as the primary liaison to the Regulatory Science and Policy Subcommittee; collaborating with outside entities; keeping abreast of such activities of international regulatory agencies; working with the FDA on initiatives, such as the AACR-FDA Regulatory Science and Policy Fellowship; and overseeing a wide array of relevant tasks and assignments that will advance the AACRs mission.

Responsibilities:
The Director, Regulatory Science and Policy will work with the AACR on regulatory science and policy initiatives and implement a range of important regulatory science andpolicy programs and activities related to the AACRs mission. The Director, Regulatory Science and Policy will help develop and advance the AACRs regulatory science andpolicy efforts through conferences, educational workshops, and other mechanisms, including:A)Coordinate FDA-AACR Co-sponsored WorkshopsThe Director, Regulatory Science and Policy will serve as the point person with the FDA on FDA-AACR Co-sponsored Workshops. B)Oversee Regulatory Science and Policy-related Events at the AACR Annual MeetingThe Director, Regulatory Science and Policy will oversee certain activities and events at the AACR Annual Meeting, including: 1.Major symposia and mini-symposia 2.Roundtable events: i.Special Regulatory Science and Policy Subcommittee meeting with the FDA ii.Closed Door Meetings between AACR, FDA, and other stakeholders iii.Meetings between the AACR, FDA, and Patient AdvocatesC)Facilitate Outreach to FDA via Draft and Final FDA GuidancesThe Director, Regulatory Science and Policy will help develop comments for the various FDA draft or final guidances that are issued. 1.Research and analyze the issues put forth in the guidance and identify specific areas of interest or concernto AACR members. 2.Coordinate communications directly with the FDA to better understand where they are seeking publicfeedback for draft/final guidances.D)Function as the Primary Liaison to the AACRs Regulatory Science and Policy SubcommitteeThe Director, Regulatory Science and Policy will coordinate with the AACRs Regulatory Science and Policy Subcommittee on important topics and suggest innovative approaches to ensure that the AACR maintains its position as the authoritative voice on regulatory science and policy-related issues.E)Submit Summaries, Position Papers, Policy Statements, and Issue Briefs on Regulatory Science and Policy-related IssuesThe Director, Regulatory Science and Policy serves as the point person on regulatory science and policy-related issues, including preparing and providing summaries, drafting scholarly and position papers, issuing briefs, developing policy statements and other related documents, and organizing sessions that include a regulatory science and policy focus at numerous AACR-sponsored meetings and events throughout the year.F)The Director, Regulatory Science and Policy will also work collaboratively with others in the AACR DC office, such as the Director, Science Policy and Legislative Affairs and the Director, Strategic Patient Advocacy and Engagement, on the policy-related issues that are cross-cutting and being addressed by them.

Qualifications:
PhD, M.D., or other doctoral degree in a science and/or health-related field.At least ten (10) years of relevant experience in a cancer science and/or regulatory science and policy-related environment, along with a keen understanding of cancer research and the related sciences. Experience in a regulatory science and policy area a plus.Knowledge of government policies and procedures, and the political process.Proven track record of accomplishments in conceptualizing and implementing complex policy projects.Superb written and oral communication skills.Excellent interpersonal skills.High degree of judgment and insight in regulatory issues.A self-starter with creativity and initiative.Demonstrated problem-solving and decision-making abilities.Strong strategic thinker with an ability to carry through an initiative and/or project to completion.Strong analytical skills and experience in managing a small team.A demonstrated ability to analyze complex political and policy issues, build evidence based arguments for policy proposals to the AACRs approval bodies, and bring conflicting points of view to consensus.Ability to interact with VIPs and all levels of management on important policy matters, including the CEO, Board members, committee members, prominent scientists, Administration and Congressional officials, corporate executives, and members of the media.Ability to multi-task and work under rapidly developing deadlines and priorities.Ability to effectively communicate the progress and future needs of regulatory science and cancer research to various constituencies.Equal Opportunity Employer