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VP, Global Head Clinical Development and Operations,

Company: Takeda Pharmaceuticals International GmbH
Location: Lexington
Posted on: February 22, 2021

Job Description:

The health and safety of our employees and candidates is very important to us. Due to the current situation related to the Coronavirus (COVID-19), we're leveraging our digital capabilities to ensure we can continue to recruit top talent at Takeda. As your application progresses, you may be asked to use one of our digital tools to help you through your recruitment journey. If so, one of our colleagues will explain how these tools will be used during the recruitment process. Thank you. *Please be aware of an Identity Theft Scheme targeting individuals seeking jobs with Takeda and other employers. See below or here for more info. VP, Global Head Clinical Development and Operations, Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda's long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole. Success What makes a successful member of our team? We take action and make decisions by focusing on our four priorities in this order: "Takeda is a unique place to work as there is no 'every-day routine' around here - it's very a dynamic environment where change of plans and adjustments of approach are the constants... This allows for interesting cross-function collaboration and - if you're up for it - a high degree of influence on your daily job and workplace." "Takeda is a great place to work as the company invests in the continuous development of its employees offering training, coaching, mentoring and open exchanges between all levels of the organization. Also, it is fulfilling to know that, within the Vaccine Business Unit, we are developing and delivering innovative vaccines impacting the lives of millions of people around the world." VP, Global Head Clinical Development and Operations, 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 the VP, Global Head Clinical Development and Operations, Vaccines Business Unit, based in Zurich Key Accountabilities

  • Leads the clinical development of vaccine candidates developed by VBU, including their life cycle management
  • Provides rigorous clinical and scientific leadership and operational excellence to enable team to translate scientific data into executable vaccine clinical development plans. Oversees design and implementation of vaccine trials, supporting their ultimate registration; responsible for the key design elements of clinical study protocols, and focusing on innovative design, execution and interpretation.
  • Provides clinical/medical expertise and collaborates with therapeutic area experts in determining opportunities for new in-licensing projects.
  • Participates in the preparation of clinical content of regulatory submissions/documents (e.g. NDA, MAA, IND, etc.) and the resolution of clinical queries from regulatory agencies and investigators and support marketed products.
  • Accountable for the medical and scientific validity of clinical studies, especially related to conclusions on efficacy and safety. Collaborates closely with study teams and, together with PV, ensures continuous risk-benefit management of Takeda`s licensed and developmental vaccines.
  • Overall strategic and operational responsibility for the successful execution of the global portfolio of clinical programs within the VBU. Oversight of study delivery, including global study management, outsourcing & contracting, risk management and third-party oversight, process and inspection readiness, and resource planning and metrics management Experience
    • Medically-qualified candidates: MD or internationally recognized equivalent plus 10-15 years of relevant experience, preferably within the vaccines industry.
    • Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions.
    • NDA/MAA/regulatory submission experience
    • Minimum of 4 years experience in Senior Management roles leading people.
    • Track record of successful development and licensure of vaccines in various jurisdictions
    • Minimum of 10 vaccine related journal publications and at least 15 vaccine related presentations preferred.
    • Basic understanding of business and financial principles
    • Capable of building organizations and developing talent. Demonstrated experience in managing global, cross-functional teams. Proven leadership skills in managing teams of culturally diverse backgrounds.
    • Ability to establish excellent working relationships and stakeholder management to align development and clinical strategies with overall business imperatives. Skills
      • Superior communication, strategic, interpersonal and negotiating skills.
      • Ability to proactively predict issues and solve problems.
      • Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams.
      • Diplomacy and positive influencing abilities across multinational business cultures.
      • Proven advanced negotiating, influencing and motivating skills.
      • Demonstrated scientific/technical leadership, and strategic planning and implementation.
      • Ability to inspire teams to work collaboratively with other VBU or Takeda Pharma functions by demonstrating enterprise leadership behaviours
      • Excellent problem solving and decision-making skills and ability to manage through ambiguity and uncertainty. Ability to think laterally.
      • Excellent planning and prioritization skills and oral/written communication/presentation skills At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realise their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver a Better Health and a Brighter Future to people around the world. Discover more at takedajobs.com. What Takeda Can Offer You To further support and inspire our employees, our benefits include: Competitive basic salary, Annual Bonus, Contributory Pension Scheme, Private Health Cover and Life Assurance. Check out where you could be
        working if you apply. Job Seekers: Protect yourself against identity theft Please be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees to steal personal information. They visit job-related websites and invite candidates to online chats. During the chat, they press job seekers to provide bank account information and Social Security numbers. Copyright 1995-2019 Takeda Pharmaceutical Company Limited. All rights reserved.

Keywords: Takeda Pharmaceuticals International GmbH, Huntsville , VP, Global Head Clinical Development and Operations,, Healthcare , Lexington, Alabama

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