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Senior Director Global Clinical Lead Contrast & Digital Radiology Solutions

The Global Clinical Lead (GCL) is responsible for the ideation, strategic conceptualization, clinical design, conduct oversight, interpretation and reporting of results of clinical studies for the

development of Radiology assets. The GCL will be responsible for the clinical development programs in Radiology which include drug compounds (e.g. contrast agents for use in MRI or CT scans), digital assets requiring clinical validation studies (e.g. artificial intelligence and machine learning in software as a medical device products) or development programs where both types of assets (contrast and digital) are combined. The GCL is responsible for Phase II and Phase III clinical development of contrast agents as well as for clinical input in Phase I within a multi-disciplinary global team. In addition, the GCL will be responsible for the clinical development plan for digital applications, from discovery phase through to the design and conduct of clinical validation studies.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Senior Manager Global Policy & Public Affairs are to:

• Define the global clinical development strategy for the assigned contrast media and/or digital assets (e.g. clinical imaging applications) or combination product developments involving contrast agents, digital and potentially electromechanical devices;
• Design, conduct, analysis, interpretation and reporting of clinical studies and other clinical documents related to the development of digital solutions and contrast media;
• Be responsible for the ongoing benefit/risk assessment of assigned assets, including the analyses of incoming clinical data during the conduct of clinical development studies, relevant medical and scientific information as well as aligning and initiating actions or decisions with other functions as appropriate;
• Be a core member of a multifunctional Global Project Team (GPT) and represent as clinical development lead function in other teams and committees as needed;
• Author clinical documentation for drug development purposes and regulatory interactions e.g. clinical development plan, clinical study protocols, clinical study protocol, clinical overviews and other regulatory submission documents, responses to requests for information;
• Author clinical documentation for digital development purposes and regulatory interactions e.g. Clinical Evauation Reports (CER) etc for 510k or DeNovo submissions, EU Medical Device Regulation (MDR),etc.;
• Lead clinical discussions with health authorities globally, as well as other external stakeholders;
• Support and collaborate with the global and regional Medical Affairs, Regulatory Affairs teams as well as other Bayer Radiology and PH functions, internal or external stakeholders and partners engaged in the development of Radiology assets.

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:

• Doctor of Medicine degree (M.D.) with a Board certification in a relevant therapeutic area (e.g. radiology, nuclear medicine, oncology)
• 5 to 10 year experience in the development of pharmaceutical drug products within the health care pharmaceutical industry
• 2 to 5 year experience in the development of medical device and/or digital products e.g. artificial intelligence and machine learning based software as a medical device
• Demonstrated experience in producing clinical development documents (e.g. clinical study protocols and reports for contrast or other drug developments, regulatory submission modules, device CER and EU MDR clinical documents)
• Proven track record of successful clinical leadership in drug, digital and device innovative development
• Experience of effectively managing risk and compliance issues as well as managing diverse multifunctional teams across cultures and geographies
• Proven leadership, motivational and interpersonal skills as well as the ability to provide clear vision, direction, and purpose in the different cultures present within a global R&D organization
• Willingness to embrace change and to work in an agile and changing environment as well as accuracy, perseverance, creativity and the ability to work under pressure, both independently and cooperatively
• Strong written and oral communication skills and high degree of fluency in written and verbal English

Preferred Qualifications:

• Extensive professional experience in imaging is a plus
• Experience in development of devices other than digital devices will be considered
• Experience in regulatory environments especially in the EU, US, APAC is preferred

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