Job Description
The Regional Medical Affairs Manager (RMAM) is a cross functional role responsible for the strategic planning, execution, and delivery of bladder cancer studies and other medical affairs activities. The role interacts with HCPs and key opinion leaders to lead clinical studies and medical affairs activities to generate high-quality clinical and real-world evidence to support medical communication, regulatory submissions, scientific publications, guidelines and product adoption. This position reports to the VP North America Head of Medical & Clinical Affairs. Key Responsibilities and Activities: External Expert Engagement: Engage/build peer-to-peer relationships with national and regional key opinion leaders (KOLs) Develop and participate in medical communication, education and training for KOLs Identify data gaps related to disease area or products based on clinical insights Participate in local and national congresses Assist in the development, implementation, and delivery of Medical Advisory Boards Clinical Study Leadership & Execution: Leads or supports the design, planning, and execution of clinical projects, which may include interventional, observational, or post-marketing (e.g. Phase 4) studies Provide input into study protocols, investigator brochures, statistical analysis plans, and clinical study reports Drive study timelines, budgets, and milestones to ensure successful delivery Lead site identification, feasibility assessments, and Site Initiation Visits (SIVs) Support onboarding and training of investigators and study staff Act as primary sponsor representative for CROs and vendors Help manage vendor performance, timelines, and deliverables Contribute to the management of sponsor studies, investigator-initiated studies (IIS/IITs), research collaborations from a scientific and operational perspective Support ongoing registry programs with a focus on data quality and site performance Publications & Evidence Dissemination: Contribute to medical communicatio