MEDICAL DIRECTOR CLINICAL EXCELLENCE, CLINICAL DEVELOPMENT,
Trabajar de Directores generales y gerentes generales en Zürich (Suiza)
Clasificación del trabajo:Directores y gerentes : Directores ejecutivos, personal directivo de la administración pública y miembros del poder ejecutivo y de los cuerpos legislativos : Directores generales y gerentes generales : Directores generales y gerentes generales. Führungskräfte : Geschäftsführer, Vorstände, leitende Verwaltungsbedienstete und Angehörige gesetzgebender Körperschaften : Geschäftsführer und Vorstände : Geschäftsführer und Vorstände.
Descripción de la oferta de trabajo:
Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Medical Director, Clinical Excellence, Vaccines Business Unit (VBU) – based in our Zurich office. This role will be responsible for Norovirus. Takeda Takeda is a global pharmaceutical leader with more than 31,000 professionals working together across 70 countries. We have an unwavering dedication to put people first and we live our values of Takeda-ism—Integrity, Fairness, Honesty, and Perseverance. We are united by our 235-year legacy of research-based pharmaceuticals and our mission to strive toward Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Watch our Medicine for the World video: Watch our Medicine for the World video. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Medical Director, Clinical Excellence, working on the Vaccines Clinical Development team, reporting into VP, Head of Clinical Development Vaccines, your typical day will include: OBJECTIVES: - The Medical Director Clinical Excellence leads and drives strategy for the overall global clinical development department medical and scientific processes and needs, taking into consideration medical, safety and scientific, regulatory and commercial issues for vaccines candidates and the clinical development department. - Establishing an effective way to manage medical and clinical development processes across the VBU clinical development organization and ensures effective way of working between clinical development and VBU stakeholders, internal Takeda partners, and external vendors. - Applies clinical/medical decision-making to clinical development issues. - Interacts with and influences VBU senior leadership and Takeda leadership. ACCOUNTABILITIES: Clinical Development Medical and Scientific Excellence and Leadership - Provides scientific expertise on the clinical development for vaccine candidates and takes accountability to support processes and alignment around medical monitoring, CDP development,the creation of regulatory documents such as investigational new drug applications (INDs), regulatory briefing documents, investigator’s brochures, investigational medicinal product dossiers (IMPD), common technical documents (CTD) as the basis for new drug applications (NDA) in the US and market authorization applications (MAA) in the EU, IND annual reports, EMA/ CHMP documents (other authorities and related documents as applicable), and scientific white papers. - Provides continual critical evaluation of the development strategy to maintain state-of-the-art development plan(s) that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them. - Supports monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications. - Part of the Clinical Development Leadership Team Due Diligence (DD), Business Development and Alliance Projects - Responsible for identification and evaluation of potential business development opportunities, conduct due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and/or in-licensing opportunities. Assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during DD visits and alliance negotiations, and representing VBU clinical development on internal assessment teams. Serves as clinical contact point for ongoing alliance projects and interface with partners to achieve Takeda’s strategic goals while striving t
Servicio de empleo de origen:SECO, Servicios Públicos de Empleo, Suiza.