Boston Scientific Senior Manager Clinical Strategist 

United States, Massachusetts, Marlborough 

284371061

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 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.
• Proven scientific writing and communication skills for scientific conferences and journals

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.