About the role:

The Senior Manager, Clinical Strategy for real-world evidence (RWE) plays a pivotal role in shaping the strategic use of real-world data (RWD) to inform Regulatory, Clinical, R&D, HEMA and commercial decision-making across the company’s vascular business. This role contributes to efforts on establishing RWE as a core strength of the Vascular business with rigorous evidence to support device development, labeling strategies, indication expansions, and market differentiation. The candidate will partner with various internal teams, including Biostatistics, Health Economics and Market Access, Legal, Marketing, Medical Affairs and Safety, Quality, R&D, Regulatory, Sourcing, along with external experts, physicians or agencies to assist in identifying strategy needs, defining fit-for-purpose use cases, overseeing developing study designs, and implementing innovative and compliant RWE solutions that support the Vascular business’ strategic goals.

Responsibilities will include:

• Drive the development and execution of vascular strategies for leveraging RWD for clinical, regulatory, marketing, business development and research purposes, such as value messaging, publications, label expansions, and post-market surveillance.
• Collaborate closely with key stakeholders including Regulatory, Biostatistics, Clinical Communications, Medical Affairs, Health Economics and Market Access (HEMA), Quality, R&D, Marketing, and Legal to align on cross-functional objectives and implementation strategies.
• Support the development of the design, execution, and analysis of RWE projects, ensuring they meet scientific, regulatory, and business requirements.
• Develop and maintain timelines, budgets, and resource plans for RWE initiatives.
• Represent the company’s Vascular division in scientific and regulatory forums, conferences, academic collaboration, health system partnerships, and working groups related to real-world evidence.
• Contribute to enterprise knowledge repositories with curated RWE studies, use cases, methodologies, and learnings to promote transparency and reusability.
• Recruit, lead, and develop a high-performing team.

Required qualifications:

• Minimum bachelor’s degree and 7 years of relevant experience in clinical strategy and/or research, including 3 years in real-world evidence or observational studies or advanced degree (MD, DO, PhD, MPH, MS) in a relevant clinical, scientific, epidemiologic, or healthcare informatics field.
• Proven experience of RWE use cases with business impact and value.
• Proven expertise in study design, protocols, analysis, and interpretation of RWE studies using claims, EHRs, registries, patient-generated data and other structured/unstructured data sources.
• Proficiency with medical coding standards (ICD, CPT, SNOMED, LOINC) and strong working knowledge of regulatory frameworks and evolving guidance for RWE use.
• Proven experience in people management.

Preferred qualifications:

• Demonstrated success leading cross-functional RWE initiatives
• Experience applying RWE in support of medical device research and development and/or regulatory submissions.
• Familiarity with advanced analytics (Machine Learning and AI), data platforms (Snowflake, AWS, Azure), programming tools (Python, R, SQL), data quality frameworks, data exchange and integration standards, and validation methodologies in observational research.