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(CAR-T) Sr. Director Oncology Cell Therapy Biomarker Development Lead

Bayer
Whippany, New Jersey, United States
30+ days ago

Description

(CAR-T) Sr. Director Oncology Cell Therapy Biomarker Development Lead 

Bayer is Hiring for several newly created Cell Therapy roles!

This position will strategically influence the use of biomarkers for decision making purposes from early development through life cycle of cell therapies, including companion diagnostic strategies. Ensuring that the cell therapy drug products enter clinical development with testable hypotheses and fit-for-purpose biomarkers and/or segmentation tools. Fully accountable for ensuring that such biomarkers and/r segmentation tools are tested for clinical utility as part of the cell therapy drug development process.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Oncology Cell Therapy Biomarker Development Lead, are to: 

  • Provide leadership for development of precision medicine approaches for MSLN CAR-T and other cell therapy programs;
  • Be responsible for strategic, clinical, scientific, technical and budgetary planning for the assigned projects;
  • Provide relevant Oncology expertise to Global Program Team (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 cell therapy Research and Development (R&D) process, informed by deep understanding of clinical development in Oncology and state-of-the-art biomarker use in Oncology;
  • 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;
  • Represent biomarker related aspects, internally and externally, in meetings with authorities and ethics committees as well as 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;
  • Analyze independently, interpret and present results from biomarker analyses and draw scientifically valid conclusions that support and enable decision making.
     


Requirements

WHO YOU ARE

 Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

 Required Qualifications:

  • MD or Ph.D.  in Pathology, Biochemistry, Molecular Biology or Genetics combined with senior management level expertise in cell therapy and Oncology space;
  • Senior level researcher with deep understanding and experience in cell therapy translational medicine, especially in Oncology;
  • At least eight years of industry experience;
  • At least five years in development of cell therapies, understanding of pathophysiology and therapies in oncology;
  • Thorough understanding of relevant fields ranging from Cellular Immunology, Cell-Engineering in the context of Oncology;
  • Focus on early stage drug development, including experience with implementing biomarker strategies in phase I, regulatory framework for bio sampling, translational medicine in 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;
  • High level of intellectual integrity and business accountability as well as team spirit;
  • Willingness to embrace new ways of working in flexible and agile teams at the interface with PH SBU Oncology and external partners and alliances;
  • Strong strategic acumen, scientific understanding and business clout to enable on-a-par interactions with C-level external collaboration partners and contacts in the industry and academia side;
  • Driven by creating value for the customer (patient);
  • Fluent and able to negotiate at C-level in English.

Job Information

  • Job ID: 57917168
  • Location:
    Whippany, New Jersey, United States
    Cambridge, Massachusetts, United States
  • Position Title: (CAR-T) Sr. Director Oncology Cell Therapy Biomarker Development Lead
  • Company Name: Bayer
  • Job Function: Industry: Research
  • Work Setting: Industry/Biotech
  • Job Type: Full-Time
  • Job Duration: Indefinite

Please refer to the company's website or job descriptions to learn more about them.

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