Senior Manager, Clinical Strategist

Job Description

Job Description

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 the company'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.

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 the company 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 :

Preferred qualifications :