- Be responsible for the global clinical development strategy within the MRI portfolio for the assigned product development, including contrast media and any synergetic MR device or digital solutions
- Direct and oversee the global clinical development including the design, conduct, analysis and reporting of Phase II-III trials through global  product registration as well as provide medical input in Phase I early development and strategic marketing supporting the radiology R&D  and business goals, including the implementation of state-of-the-art development approaches e.g. real world evidence
- Shape the clinical value propositions of planned product offerings by optimizing product value (e.g. scientific differentiation, identification of  new indications, new formulations and new populations of use)
- Be core member (m/f/d) of the multifunctional global project team representing medical and clinical affairs as well as actively seek  exchanges and cooperation with scientific departments within radiology and Bayer R&D
- Prepare the clinical development plan (CDP) and key documents (e.g. medical sections of Regulatory documents andIB) in consultation  with relevant key disciplines and be responsible for planning and managing the clinical timelines and budget against the approved CDP as  well as the approved resources
- Be responsible for the ongoing benefit-risk assessment of assigned products, including the analyses incoming clinical data during the  development, relevant medical and scientific information and initiate actions or decisions with other functions as appropriate
- Plan and conduct medical advisory boards, establish and maintain a thought leader global network and other external stakeholders, in  collaboration with the strategy identified within regional and local medical and clinical affairs
- Provide clinical input and support (e.g. communication of clinical strategy and results) in health authority interactions related to the  radiology portfolio as needed as well as perform clinical review and be responsible for approval of medical content in medical and  promotional material for global use

Job requirements

- M.D. or a similar qualification combined with long-term experience in pharmaceutical development in industry positions; experience in drug development, device development, digital development and clinical practice experience is preferred
- M.D. board certification in a relevant therapeutic area (e.g. Radiology or Nuclear Medicine); highly successful and extensive professional  and academic experience in imaging is preferred
- In-depth knowledge and experience with the pharmaceutical clinical development and regulatory environments, especially in the EU, US  and APAC; knowledge and experience of medical device development and digital development is a plus
- Demonstrated experience in developing clinical development documents e.g. clinical study protocols and reports, regulatory submission  modules (e.g. clinical overview, summary of clinical efficacy and summary of clinical safety), medical review reports, pediatric investigation  plan and pediatric study plan
- Experience of effectively managing risk and compliance issues and in managing diverse multifunctional teams across cultures and  geographies
- Proven leadership, motivational and interpersonal skills as well as the ability to provide leadership in a matrix structure e.g. proven skills in  driving a vision, gathering information, negotiation, decision-making as well as communicating decisions and action plans
- Strong written and verbal communication skills to ensure that project plans and status are transparent, and that risks, issues, and results  are clear to all involved parties as well as the ability to provide clear vision, direction, and purpose in the different cultures present within a  global R&D organization
- Fluent in English, both written and spoken

Job details
Education field:
Work experience:
Work experience is not required
Language skills:
  • English
  • Fluent
Number of positions:
1
Date of expiry:
About company

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. Read more

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