Senior Director, Companion Diagnostics Lead

 

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Senior Director, Companion Diagnostics Lead 

 

The Senior Director, Companion Diagnostics Lead (CDxL) will execute global diagnostic strategies for Bayer's Precision Medicine portfolio. This role involves collaborating with diagnostic partners, IPT members, and other 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.

 

The Senior Director, Companion Diagnostic Lead builds an end-to-end Diagnostic strategy and is responsible for its successful execution for all development programs on behalf of TSO, 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 CDxL 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, Senior 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, the CDxL is responsible for implementing CDx strategies throughout precision drug development, from early clinical stages to on-market support & life cycle management. You will ensure 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;
• Guides and extensively contributes to the growth of IVD/diagnostics knowledge and capabilities in the organization.