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Director, Clinical Science Lead

The Clinical Science Lead is a key figure for leading the clinical science perspective within the global Oncology development programs. The Clinical Science Lead creates significant impact through safeguarding the quality and integrity of ONC studies and related medical data, optimizing decision making and thereby drug development within a trial's framework.

In this role, you are assigned to highly complex and/or strategic priority clinical studies and provide scientific leadership to develop challenging protocol/study designs with full decision-making authority in your sphere of influence.

The CSL ensures a scientifically sound end-to-end study strategy, responding to atypical study operations, high study financial costs, large global clinical trial scope, and/or new areas of investigation. In addition, you will serve as the liaison for all clinical-scientific aspects of a trial within the study team and provide clinical science expertise within preclinical projects. The CSL is accountable for significantly shaping functional excellence within Early Clinical Development Oncology by driving core project, people, and innovative clinical development topics under a peer-reviewed setting, as well as pushing the boundaries of drug development in close collaboration with internal and external researchers.

YOUR TASKS AND RESPONSBILITIES

The primary responsibilities of the Clinical Science Lead are to:

• Act as the scientific leader and primary clinical-science representative for the global program(s) assigned;
• Perform scientific oversight of oncology clinical trials and ensure scientific integrity of the study from concept to final report. In this role, you will participate in the development of the Clinical Development Strategy and Plan and provide expertise to various deliverables necessary for effective and efficient execution for the program;
• Plan and execute all matters related to data-driven decision making, focusing on patient centricity, urgency and speed ensuring a sound data-driven strategy. As such, the CSL is responsible for all clinical science related aspects and supports/partners with the Integrated Product Med Lead and other clinical trial scientists on overall study planning, preparation, management, evaluation, and documentation;
• Promotes a creative and innovation-friendly collaboration between clinicians and scientists to evolve Early Clinical Development Oncology's unique value contribution and the development of a robust pipeline and thereby drives the development of a productive and fulfilled workforce by embracing a culture of creativity and innovation, while ensuring that capabilities are available and actively evolving;
• Takes ownership for the entire Early Clinical Development Oncology team, fosters a culture of ownership in support of the strategy and in line with the Bayer's values. Empowers others and drives peer accountability across portfolio deliverables and beyond;
• Can lead and drive ECDO-initiated (cross-)functional strategic initiatives in support of the overall ECDO, RED-ONC, Oncology and/or Bayer strategy;
• Independently leads self-empowered matrix teams in-line with Bayer's VACC leadership standards by enabling, empowering, and supporting colleagues in a high-performance environment under a culture of psychological safety. He/She takes accountability for the respective team outcomes.

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:

• Advanced degree in health/life science-related field;
• Outstanding drug development expertise;
• Ability to acquire knowledge of different diseases and therapeutic areas;
• Relevant global health authority interactions and current knowledge of regulatory review and responses;
• In-depth knowledge of GCP/ICH, FDA, EMA, and other relevant guidelines and regulations;
• Adapts quickly to and promotes change and fosters innovation, sets the right priorities, seizes strategic opportunities, and adheres to high standards;
• High energy with focus and vision; self-motivated with a high sense of ownership, urgency, proactive and solution-oriented, flexible entrepreneurial and open-minded approach to new and creative ideas;
• Focuses on outcomes - independently defines and proactively delivers on highest and aspirational pipeline, team, talent and organizational impact outcomes;
• Acts, learns fast and evolves: works in 90-days cycles, applies learnings very fast and continually develops;
• Co-creates for customers: remains close to the customer - envisions, proactively conceptualizes and co-creates solutions for their needs.

Preferred qualifications:

• Advanced degree in health/life science-related field with a minimum of 4 years of industry experience in a pharmaceutical/biotech business;
• Oncology experience.