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Your tasks and responsibilities
The primary responsibilities of this role, Director Biomarker Strategy (Clinical Development), are to:

Will be biomarker project leader (BPL) for one or more development programs and resume in this role strategic, clinical, scientific, technical and budgetary planning for the assigned biomarker projects. Act as an equal member of the GPT, when required. Will provide relevant Oncology expertise to GPT when evaluating and developing translation and biomarker strategies;
Acts as thought partner to ER leaders, proactively following early projects prior to D2, and taking an active role from D2 onwards, assembling resources for subsequent biomarker activities on the project. Will draw on resources from across the organization, particularly the TRGs, to ensure delivery of appropriate biomarker strategy;
Ensures 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;
Defines, communicates and executes on the biomarker strategy for each development program where he/she is BPL; represents biomarker related aspects internally and externally in meetings with authorities and ethics committees, and with external key opinion leaders; builds and maintains network with academic institutions/diagnostic companies in Oncology. Will work closely with ECL to ensure translation strategy has maximum success rate supported by a developable biomarker;
Leads 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;
Who you are
May be nominated as Clinical Pharmacology Leader (CPL) or Early Clinical Leader (ECL). In this role he/she leads the global CS team and independently creates, updates and implements the CS development plan. He/she presents it on internal decision making committees, represents CS in global project teams and coordinates the preparation and submission of the CS dossier;
Independently analyses, interprets and presents results from biomarker analyses and draws scientifically valid conclusions that support and enable decision making.

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:

Medical doctor (MD) and/or PhD in Biochemistry, Molecular Biology, or Genetics;
Proven track record of research and/or clinical development in Oncology, including a minimum of 10 years combined experience in industry and academic/research;
Thorough understanding of pathophysiology and therapies in oncology;
Focus on biomarkers (incl. patient stratification for personalized medicine), including experience with regulatory framework for bio sampling, biomarkers, 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 in the absence of formal reporting lines;
Excellent interpersonal and communication skills (fluency in English, oral and written), confident team player, assertive but willing to listen and to seek and learn from the views of others;
Strategic influencing skills with experience in stakeholder management at leadership team level; able to set and communicate a strategic vision


Associated topics: clinical, clinical development, clinical informatics, clinical trial, coordinator, lab, laboratory, research, research coordinator

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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