Director, Companion Diagnostics Lead

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Director, Companion Diagnostics Lead 

YOUR TASKS AND RESPONSIBILITIES

The Director, Companion Diagnostic Lead (CDxL) will be responsible for the execution of global Diagnostic strategies within the Bayer Precision Medicine driven portfolio of products. The role will engage with diagnostic partners, IPT members and other external key stakeholders.

This position will work closely with Diagnostics strategic partners to drive the development of Companion Diagnostics with appropriate partners enabling co- registration with drug as appropriate. To achieve this the role will work closely with Clinical Development, Statistics, Data management, Regulatory, Medical Affairs and Commercial/Marketing functions. You will build an end-to-end Diagnostic strategy and are responsible for its successful execution for multiple development programs on behalf of Translational Sciences Oncology, providing CDx leadership for one or more global development programs with full decision-making authority in his/her sphere of influence.

Together with cross-functional IPT members the Director, Companion Diagnostic Lead drives the creation and maintenance of a seamless strategy for patient selection during clinical development and for precision drug on market to maximize the success of development programs and significantly shapes the value of the product, ultimately driving data driven decisions and highly competitive drug labels.

Key Responsibilities:

The primary responsibilities of this role, Director, Companion Diagnostic Lead are to:

Portfolio Responsibilities:

• Responsible for the comprehensive companion diagnostic strategy delivered to the IPT, strategically directing the global CDx activities by providing relevant expertise and leadership in precision medicine both professionally and scientifically. As such, the CDxL ensures consistent high quality and speed of deliverables for patient selection clinical trial assay and Dx products to drive sustained value creation for patients and the business. You will ensure an “end-to-end” CDx vision and strategy for the respective asset(s). The CDxL pushes the boundaries of seamless Dx strategy and implementation to select the right patient at the right time, to fulfill regulatory commitment and enable commercial success, thus optimizing access to the right drug, with a patient-centric perspective;
• Based on this vision, you will be responsible for implementing CDx strategies throughout precision drug development, from early clinical stages to on-market support & life cycle management.
• Ensures critical input and continued support of clinical projects with diagnostics development expertise, designing companion diagnostics meeting various HA requirements and commercial needs, taking local requirements (e.g., IVDR) into account.
• Ensure an innovative, advanced global CDx lineup by developing a patient-centric vision, setting up and steering strategic partnerships with diagnostic developers and testing providers. In this regard he/she may be a member of joint steering committees/project team to maximize value in support of the Bayer oncology portfolio;
• Accountable for the timely delivery of CDx milestones, mitigates roadblocks and is empowered to take decisions to effectively execute on the CDx strategy;
• Contributes to the growth of IVD/diagnostics knowledge and capabilities in the organization.

Responsibilities beyond portfolio:

• In alignment with the overall oncology strategy and Precision Medicine community, identifies new opportunities for collaboration and manages excellent relationships with new and existing partners, both within as well as outside of Bayer, to drive Precision Medicine excellence;
• Participates or independently leads self-empowered matrix teams in-line with Bayer’s VACC (Visionary, Architect, Catalyst, Coach) leadership standards by enabling, empowering, and supporting colleagues in a high-performance environment under a culture of psychological safety. As such, you will take accountability for the respective team outcomes and promotes a creative and innovation-friendly collaboration between clinicians and scientists;
• Takes ownership, fosters a culture of ownership in support of the strategy and in line with Bayer’s values; empowers others and drives peer accountability across portfolio deliverables and beyond;
• Evolves Translational Science Oncology’s unique value contribution 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.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Medical doctor (MD) and/or PhD in Biochemistry, Molecular Biology, or Genetics
• Thorough understanding of diagnostics and therapies in oncology;
• Experience with companion diagnostic development including quality system and regulatory framework;
• Understanding of scientific, commercial, regulatory, ethical, and legal aspects in the field;
• Comfortable to represent area of responsibility in complex environment;
• Able to co-create and communicate a strategic vision;
• Excellent interpersonal and communication skills (fluency in English, oral and written);
• Experience in leading cross-functional internal team and driving cross-company project team to achieve deliverables on schedule;
• Applies our VACC leadership behaviors;
• Demonstrates high self-awareness as well as system awareness;
• Pro-actively asks for and gives feedback;
• Demonstrates strategic thinking as well as good business and external trends insights; 
• Focuses on outcomes: defines and deliver highest pipeline, team, talent, and organizational impact outcomes;
• Collaborates with accountability: collaborates and holds each other accountable in and across teams; 
• Co-creates for customers: is close to the customer and co-creates solutions for their needs; 
• Acts, learns fast and evolves: works in 90-days cycles, applies learnings fast and continually develops;
• Is the best self and includes others: respects differences, embraces inclusion and shows up as the best self. 

Preferred Qualifications:

• 6+ years of industry experience or 8+ years overall experience in the field of diagnostic development with proven track record.

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