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Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Lead Global Operation Excellence and Project Management MA Oncology
The Associate Director/ Lead Medical Affairs Oncology Clinical Operations is accountable for management of all aspects and ensuring high quality of program clinical trials (phase I-IV, Expanded Access, Investigator Sponsored registries/ studies, and Compassionate Use) including leading Medical Affairs cross functional Clinical Trial Team(s) (CTT).
Ability to manage ISS program and manage phase I-IV clinical trials including EAP, CUP and non-interventional studies. Leads a portfolio of compounds. Independently translate the Medical Affairs Plan into clinical protocols and related documents: lead the clinical trial protocol development process including driving the new science by incorporation of innovative designs; contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions; obtain approval from internal review boards. Protocol will be written in collaboration with the Global Medical Affairs Lead.
Develop and maintain effective working relationship with key investigators in assigned program to optimize scientific quality/innovation of clinical study design, execution, reporting and publication. Lead trial-related scientific meetings. Lead protocol training meetings.
Lead and matrix manage the global multidisciplinary Clinical Trial Team (CTT) to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures: chair CTT meetings, report study progress and issues with their resolution plan to International Clinical/Program Teams.
Lead the clinical trial data ongoing medical/scientific re-view, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations.
Develop clinical outsourcing specifications incorporation with respective line functions to facilitate bid templates and selection of CROs; manage interface with CROs in cooperation with the Contract Management Department.
Forecast trial resources needs (headcount and external costs): accountable for the development, management and tracking of trial budget working closely with the appropriate groups in Oncology.
Supporting the Medical Affairs lead in the coordinate the GMA support to the development of clinical sections of regulatory documents. Establish strong clinical relationships globally to develop clinical champion network to participate in clinical studies and other evidence-based marketing initiatives. Collaborate with the Medical Affairs Team with study initiation visits for new clinical study centers, including center recruitment and preparation, facilitating IRB approval process and preparation for enrollments. Manage publications including global strategy, key clinical interest targets, physician author selection and management, and execution. Provide initial and transitional education for clinical center personnel and sales representatives on protocol, clinical process, products and applications. Understand working relationships with KOLs across functions and be able to leverage relationships to create and execute strategically aligned activities. Develop and maintain strong clinical knowledge, critical market insight, and industry awareness to guide strategic decision making.