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Companion Diagnostics Lead

vor 2 Monaten


Berlin, Berlin, Deutschland Bayer Vollzeit

About Bayer

Bayer is a global leader in the life sciences, driven by a vision to make a difference in the world. We're a community of innovators, thinkers, and doers, united by a shared purpose: to create a world where health and hunger are no longer challenges, but a reality.

Companion Diagnostics Lead Role

We're seeking a seasoned Companion Diagnostics Lead to join our Precision Medicine team. As a key member of our global diagnostics strategy, you'll collaborate with cross-functional teams to develop and implement comprehensive diagnostic strategies for our Precision Medicine portfolio.

Key Responsibilities:

  • Strategy Development: Design and execute global diagnostic strategies, ensuring high-quality and timely deliverables for clinical trial assays and diagnostic products.
  • Collaboration: Work closely with Clinical Development, Statistics, Data Management, Regulatory, Medical Affairs, and Commercial/Marketing teams to drive companion diagnostic development.
  • Patient Selection: Implement CDx strategies throughout precision drug development, from early clinical stages to on-market support & life cycle management, meeting various HA requirements and commercial needs, taking local requirements (e.g., IVDR) into account.
  • Innovation and Partnerships: Establish strategic partnerships and push boundaries in diagnostic strategy and implementation.
  • Decision-Making: Take full accountability for CDx strategies, making data-driven decisions to optimize patient access and regulatory compliance.

Beyond Portfolio:

  • Identify new collaboration opportunities and maintain excellent relationships with partners.
  • Lead self-empowered matrix teams, fostering a culture of ownership, creativity, and innovation.
  • Evolve TSO's value contribution, promoting a high-performance, psychologically safe environment.

Requirements:

  • Medical doctor (MD) and/or PhD in Biochemistry, Molecular Biology, or Genetics.
  • Extensive industry experience or long-term overall experience in diagnostic development.
  • In-depth understanding of oncology diagnostics and therapies.
  • Proven experience in companion diagnostic development, including quality systems and regulatory frameworks.
  • Strong network in the academic and clinical community of Oncology, Regulatory, Diagnostics, and Pathology.
  • Excellent interpersonal and communication skills, with fluency in English.
  • Ability to lead cross-functional teams and manage cross-company projects.
  • Strategic thinker with business and external trends insights.
  • Committed to Bayer's VACC leadership behaviors and values.