• Job Description

  Req#: 788668

  At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

  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

  #LI-GH

  YOUR APPLICATION

  Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer. To all recruitment agencies: Bayer does not accept unsolicited third party resumes. Bayer is an Equal Opportunity Employer/Disabled/Veterans Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
  IMPORTANT NOTE for POTENTIAL US CANDIDATES: Bayer expects its colleagues to be fully vaccinated against COVID-19. Bayer defines fully vaccinated in alignment with CDC which is two weeks after completing the two-dose vaccine regimen or two weeks after completing the one-dose regimen. Additionally, Bayer colleagues are also required to comply with state, local and customer requirements.
  Location:	United States : New Jersey : Whippany
  Division:	Pharmaceuticals
  Reference Code:	788668

  Contact Us
  Email:	hrop_usa@bayer.com

• About the company

  Bayer AG is a German multinational pharmaceutical and life sciences company and one of the largest pharmaceutical companies in the world.

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