Senior Manager, Clinical Strategist

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.       

About the role :

The Senior Manager, Clinical Strategist 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 Boston Scientific’s diverse business units. This role contributes to efforts on establishing RWE as a core strength of the company with rigorous evidence to support device development, labeling strategies, indication expansions, and market differentiation. The incumbent will work across divisions, collaborating dynamically with various internal teams, including Biostatistics, Business Development, Communication, Digital Health, Health Economics and Market Access, IT, Legal, Marketing, Medical Affairs and Safety, Quality, R&D, Regulatory, Sourcing, along with external experts or agencies to assist in identifying strategy needs, defining fit-for-purpose use cases, developing study designs, and implementing innovative and compliant RWE solutions that support the company’s strategic goals.

 

Work Mode: 
This role follows a hybrid work model requiring employees to be in our Marlborough, MA office at least three days per week.  

 

Your responsibilities will include: 

• Drive the development and execution of enterprise-wide 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 with divisional leaders as a core member of the RWE executive committee to guide the identification, prioritization, design and scientific execution of real-world clinical use cases using claims, electronic health records (EHR)s, registries, and other RWD sources, while ensuring rigor in study quality, validity and applicability.  
• Serve as a scientific lead and subject matter expert in translating clinical need to RWE regulatory use cases, providing best practices for RWE study development and clinical validation framework, and collaborating with regulatory and clinical affairs to identify global submission pathways and appropriate evidence requirements.  
• 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.  
• Serve as a core member of an agile team that spearheads global RWE initiatives across the business.  
• Represent Boston Scientific in scientific and regulatory forums, conferences, academic collaboration, health system partnerships, and working groups related to real-world evidence.  
• Author scientific documents including study protocols, analysis plans, regulatory reports, impactful conference proceedings, books or book chapters, and publications in peer-reviewed journals.  
• Contribute to enterprise knowledge repositories with curated RWE studies, use cases, methodologies, and learnings to promote transparency and reusability.  

 

Required qualifications:  

• Minimum bachelor’s degree and 7+ years of relevant experience in clinical strategy and/or research, including at least 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.  

  

Preferred qualifications:  

• Demonstrated success leading cross-functional RWE initiatives in a regulated environment – label revisioning, post market safety and effectiveness  
• Experience applying RWE in support of medical device research and development and/or regulatory submissions.  
• Familiarity wi