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Medical Director or Senior Medical Director, Clinical Science - Marketed Products Group

Company: Takeda Pharmaceuticals International GmbH
Location: Cambridge
Posted on: April 4, 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. Medical Director or Senior Medical Director, Clinical Science - Marketed Products Group 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. As one of the world's leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units. We are a passionate team doing important work that impacts patients' lives. If you are driven to create better health and a brighter future, join us! Success What makes a successful member of our team? Check out the traits we're looking for and see if you have the right mix. Life at Takeda A Global Top Employer Recognized for our culture and way of working, we're one of only select companies to receive Top Global Employer -- status for 2021. Medical Director or Senior Medical Director, Clinical Science - Marketed Products Group Job ID R0025160 Date posted 03/13/2021 Location Boston, Massachusetts By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as Medical Director or Senior Medical Director of Clinical Science for the Marketed Products Group in our Cambridge, MA office. The Senior/Medical Director (S/MD), Clinical Science, for the Marketed Products Group (MPG) leads and drives strategy for the overall global and regional clinical science programs of assigned Takeda products, taking into consideration the clinical development, medical, scientific, regulatory and commercial issues. She/he is expected to work in a collaborative fashion across different functions and levels of management but able to accomplish tasks with the independence, based on task demands, work experience and skills, and decision-making process. The S/MD reports to the VP and Head of Clinical Science for MPG and does not have direct reports. The S/MD leads a multi-disciplinary matrix team through simple and complex decisions, by assessing and integrating input from various functions and disciplines with the goal of creating and executing clinical science/development plans with the highest scientific and ethical standards and applicability to specific regulatory requirements. The S/MD interacts with and influences MPG senior leadership decision-making by setting strategic direction and updating on implementation progress and issues. Main responsibilities

  • Clinical Science activities related to the planning of clinical trials, including preparation and presentation of clinical trial synopses and protocols for review and approval by MPG senior leadership
  • Oversight of medical monitoring activities, assessment of issues related to protocol conduct and individual subject safety and toleration, preserving the highest standard of scientific integrity and ethics
  • Assessment of overall safety data for assigned products in collaboration with Safety and Pharmacovigilance
  • Interpretation of results of clinical trials and internal subject matter expertise for the assigned products and related therapeutic area also for potential due diligence assessment of licensing opportunities
  • Resource to Clinical operations for direction and management of collaborations with Clinical Research Organizations (CRO) and other cross-functional team members involved in the execution of clinical trials
  • Resource to Regulatory affairs for expertise, responsibility and leadership on preparation and presentation of clinical/medical components of regulatory filings and for interactions with Regulatory Authorities
  • Presentation of study results to internal and external audiences and assessment of study results' impact on the overall product strategy
  • Identification, engagement and management of key opinion leaders relevant to assigned products and therapeutic area for the consultation needs that the S/MD responsibilities might require Qualifications
    • Medical degree or internationally recognized equivalent
    • 5-10 years of clinical research experience (also combined) within the pharmaceutical/biotech industry or CROs.
    • Experience in Oncology is preferred.
    • Background in Clinical Development is preferred Job Posting excludes CO applicants Skills
      • Superior communication, strategic, interpersonal and negotiating skills
      • Ability to proactively predict/identify issues and research/understand their root causes
      • Pragmatic approach to problem solving
      • Ability to drive decision-making within multi-disciplinary, matrix teams, while stimulating feedback and respecting diversity and potential differences of input
      • Diplomacy and positive influencing abilities WHAT TAKEDA CAN OFFER YOU:
        • 401(k) with company match and Annual Retirement Contribution Plan
        • Company match of charitable contributions
        • Health & Wellness programs including onsite flu shots and health screenings
        • Generous time off for vacation and the option to purchase additional vacation days 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, Cambridge , Medical Director or Senior Medical Director, Clinical Science - Marketed Products Group, Executive , Cambridge, Massachusetts

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