Through collaborations with customer clinicians and cross-functional internal relationships, establish the scientific clinical evidence and support for Bracco Medical Technologies (BMT) product differentiation. Execute product-specific clinical research strategies and provide analytical, scientific, and strategic support to product roadmaps for BMT's medical devices. The scope of responsibility spans pre-clinical, clinical, post-market and life-cycle development programs for global geographies. Support regulatory, marketing, sales, and product development initiatives with current knowledge state-of-the art and clinical applications for assigned products. Professionally and credibly represent BMT when presenting to numerous audiences: physicians, clinical staff, vendors, clinical and advisory boards, and internal customers. Ensure clinical claims are appropriate and supported by valid scientific evidence for assigned products. Contribute to sales and marketing materials intended to educate and inform customers.
Regulatory and Marketing Collaboration Activities
- Consistently meet compliance deliverables relevant to clinical studies and research, including the development of Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) Plans and Reports, and Summary of Safety and Clinical Performance (SSCP) Reports. Deliverables should reflect excellent writing and accurate, complete and relevant information.
- Support the development of medical device labeling, including promotional materials. Provide appropriate clinical references and support based on valid scientific evidence.
- Review and appropriately edit promotional materials including speaker decks, advertising materials, and white papers.
Scientific Evidence Activities
- Participate in product-specific cross-functional teams to develop, interpret, and utilize clinical evidence of BMT products throughout the company.
- Serve as the clinical lead for creating/editing clinical claims matrices for multiple products, working collaboratively on inter-departmental teams.
- Develop reports, presentations, and reviews to support scientific communications.
- Maintain comprehensive literature database for BMT products.
- Identify clinical evidence gaps to help form BMT's clinical research strategy.
- Maintain and disseminate clinical evidence summaries/briefs.
Clinical Affairs Activities
- Create and/or revised Clinical Affairs Standard Operating Procedures (SOPs) as needed.
- Review proposals for investigator-initiated studies for alignment with business needs and in collaboration with marketing.
- Facilitate review of proposals in accordance with standard operating procedures.
- Participate in annual budget planning.
- Collaborate with biostatisticians on the creation of statistical analysis plans and reports.
- Provide ad-hoc literature reviews as requested by cross-functional colleagues or teams.
- Effectively manage third-party vendors for outsourced Clinical Affairs work.
- Initiate and write position papers on Clinical Affairs related subjects, with management approval.
Product Development Activities
- Provide competitive clinical trial analysis on assigned products as needed.
- Support development of communications and labeling materials.
- Serve as an internal expert on emerging, leading and market differentiating clinical topics.