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Online Laboratory Magazine
01/20/2022

Senior Director Oncology Precision Medicine Lead

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Required Qualifications:

  • M.D. (Medical Doctor) or Ph.D., or M.D./Ph.D. preferred in the areas of Pathology, Biochemistry, Molecular Biology, or Genetics;
  • Proven track record of clinical development in Oncology with 8+ years of industry experience; understanding of pathophysiology's and therapies in oncology;
  • Focus on Immuno-Oncology drug development, including experience with implementing biomarker strategies, regulatory framework for bio sampling, translational medicine in Immuno-Oncology;
  • Outstanding scientific reputation as evidenced by multiple publications in peer reviewed journals and as speaker of conferences;
  • Strong network in the academic and clinical community of Oncology;
  • Strong leadership skills, comfortable to marshal resources from different parts of the organization.

Responsibilities of this role are to:

  • Develop one or more programs and resume in this role strategic, clinical, scientific, technical and budgetary planning for the assigned projects;
  • Act as an equal member of the GPT. Will provide relevant Oncology expertise to GPT when evaluating and developing precision medicine strategies;
  • Act as thought partner to research leaders, proactively following early projects and taking an active role from pre-IND, assembling resources for subsequent biomarker activities on the project;
  • Draw on resources from across the organization, to ensure delivery of appropriate biomarker strategy;
  • Ensure coordination of all aspects of biomarker delivery in synchronization with the drug R&D process, informed by deep understanding of clinical development in Oncology and state-of-the-art biomarker use in Oncology. Will own, source and develop distinctive biomarker knowledge to support Bayer differentiation strategy, when necessary;
  • Define, communicate and execute on the biomarker strategy for each development program where he/she is PML;
  • Represent biomarker related aspects internally and externally in meetings with authorities and ethics committees, and with external key opinion leaders;
  • Build and maintain network with academic institutions/diagnostic companies in Oncology;
  • Work closely with clinical leaders to ensure translation strategy has maximum success rate supported by a developable biomarker;
  • Lead via internal and external collaborations the development of biomarkers and/or segmentation tools for internal decision making and/or as intended part of the product definition, whether to measure response (to aid dose finding or as surrogate endpoint) or to identify patient segments;
  • Ensure regulatory compliance of biomarker activities and drive biomarker qualification processes;
  • Independently analyze, interpret and present results from biomarker analyses and draws scientifically valid conclusions that support and enable decision making.


» Job description


Employer:
Bayer AG
Location:
Residence Based [USA]
Temporary:
No
Part-time:
No