- 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
- 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
