US Lead - Oncology, Global Regulatory Policy & Innovation

Responsibilities

• Anticipate, assess, and influence US regulatory policy impacting innovative drug development.
• Create and amplify relationship-building opportunities with U.S. regulators and key external stakeholders in the regulatory policy landscape.
• Advance Takeda‚Äôs reputation as a thought leader and valued partner in prioritized areas of regulatory policy.
• Provide strategic, directional, and tactical guidance to product teams and business units, leveraging experience to assess the impact of external regulatory changes on Takeda‚Äôs priorities. Support the development of strategies and positions, and drive appropriate actions aligned with Takeda‚Äôs therapeutic areas and development projects.
• Serve as US expert and subject matter lead for regulatory policy and advocacy activities, as assigned, based on global and regional policy priorities.
• Collaborate with GRPI team to create global and regional vision for drug development and regulatory environment.
• Internal Relationships + Team Engagement Develop and maintain strong working relationships with GRA LT, GRA Heads of Therapeutic Area Units, Regulatory Affairs Leads, and GPT leaders.
• Product + Pipeline Strategy Provide partnership to support product and pipeline strategy teams, developing precedent research and analysis, and developing external pre-competitive engagements relevant to product pipelines.
• Advance Takeda‚Äôs Progressive Regulatory Posture Utilize experience, industry contacts and external partners / consultants to facilitate and provide strategic guidance to internal program teams regarding engaging and building reputation with regulatory agencies, mitigating regulatory risks, and advancing ideas for innovative approaches to engagement.
• Oversee strategic use of regulatory consultants, maintaining a network of experts and facilitating team engagements in consults.
• Excellence in issue spotting and proactive engagement maintain internal awareness and understanding of external regulatory developments, and utilize experience to oversee the strategic assessment of external regulatory changes on internal pipeline. Drive change, as needed.
• Designing and Executing on External Advocacy Initiatives With internal SMEs, identify key region-focused regulatory policy priorities directly relevant to internal pipeline development and build external advocacy strategy to target significant change.
• External Trade Association Management and Assessment Coordinate and manage Takeda engagement within trade association, PhRMA, provide direction for Takeda SMEs, and communicate activities and intelligence to internal stakeholders.
• Engagement in External Forums and Workshops Identify and negotiate external opportunities that bridge external policy priorities with internal product development, including CPath, NORD, Friends of Cancer Research, and other similar forums. Support, coordinate and lead Takeda SMEs in engagement within external forums and workshops as appropriate.
• Support Global Head, GRPI in staffing senior executives on external Boards and Committees.
• Regional Collaboration + Partnership Work and support the global GRPI team to provide globally-focused and coordinated ‚Äúone-voice‚Äù policy engagement.
• Internal Process Improvements + Automation Identify opportunities to improve GRPI and GRA information management, tracking, metrics, and to simplify workflows through automation and the use of digital tools.
• Internal Community / Culture Engagement Display leadership behaviors within Takeda to build the GRA Community and Culture.

Qualifications

• PhD, PharmD, MD, or equivalent strongly preferred. Proven track record working with FDA and regulatory strategy teams in the pharma industry in a policy capacity.
• A minimum of 15 years of combined experience in the pharmaceutical industry, FDA law or policy, and/or scientific or regulatory policy.
• Strong knowledge of regulations and guidance governing drugs and biologics in all phases of development, including post-marketing, in the US, with a understanding of basic regulatory requirements in other global markets (Japan, EU) and emerging markets.
• Understands and interprets scientific issues across projects and therapy area(s) of responsibility as it relates to regulatory requirements, policy and strategy for the region.
• Excellent collaboration/relationship building, strong influencing and negotiation skills, integrity and adaptability. Outstanding written and oral communication skills as well as managing and adhering to timelines. Proven success at stakeholder engagement across organizational levels and boundaries.
• Must be strong communicator, and ability to explain complex regulatory issues, trends, and strategies to a wide range of stakeholders
• Must be strong leader that creates vision for group. Inspires and motivates group. Takes stand on important issues in productive, respectful way. Able to mentor and develop skills of staff.
• Experience managing external partnerships with patient advocacy organizations, consortia, and/or professional societies.
• Experience managing relationships with contractors.