Director, Evidence and Innovation

Director, Evidence and Innovation

• Establish and lead a high-performing Evidence and Innovation team, with deep expertise in RWE, patient reported outcomes, economic evidence (matched-adjusted indirect comparison, indirect treatment comparison), biostatistics, epidemiology, and data science.

• Define and implement the team’s operating model, organizational structure, and core capabilities to deliver impactful evidence across therapeutic areas.

• Recruit, mentor, and develop talent to foster a culture of excellence, agility, and scientific rigor.

• Lead strategic planning and management of internal and external resources—including FTEs, contractors, and vendors—to ensure timely, high-quality execution of evidence generation activities across the portfolio

• Lead the development and execution of HEOR, Medical Affairs led RWE, PRO, economic evidence strategies that support clinical development, payer and regulatory submissions.

• Ensure that research questions, study designs, and analytic methods are aligned with strategic objectives and reflect high scientific standards.

• Oversee the generation of timely, clinically relevant, and methodologically sound evidence that informs decision-making across the product lifecycle.

• Develop study protocols, and study reports for internally lead HEOR, Medical Affairs led RWE, PRO, Economic modelling studies

• Establish and lead HEOR and Medical study governance frameworks (e.g., protocol review committee) to ensure RWE, PRO, Economic evidence initiatives led by HEOR meet scientific, regulatory (e.g., FDA guidance on CFL, Patient-Reported Outcome Measures) and ethical standards—including global privacy and data use regulations (e.g., HIPAA, GDPR).

• Ensure alignment with evolving regulatory standards such as the FDA’s guidance on PRO measures and the Patient-Focused Drug Development (PFDD) framework.

• Lead the development, review, and quality control of protocols, statistical analysis plans, and study reports, ensuring consistency, transparency, and audit readiness.

• Ensure that data governance practices align with internal policies and governance structures, and that all research activities are conducted in compliance with applicable data privacy laws, ethical standards, and institutional review requirements.

• Ensure research initiatives adhere to scientifically justified methodological frameworks, including well-defined inclusion/exclusion criteria, clinically relevant population and outcome definitions.

• Lead the identification, piloting, and integration of innovative approaches to evidence generation—including novel study designs, AI based evidence LCM and analytics, and digital health data.

• Develop and disseminate best practices and guidance for modern RWE, PRO, and economic modeling methodology, study design, and analytics across the organization.

• Champion a culture of continuous innovation, enabling experimentation with new tools, platforms, and external partnerships.

• Engage externally with academic institutions, industry consortia, and regulatory or payer/HTA bodies to stay at the forefront of innovation and evidence standards.

• Partner closely with colleagues across HEOR Strategy, Medical Affairs, Clinical Development, Market Access, Biostatistics, Regulatory, Commercial and Corporate Strategy to prioritize data needs and integrate RWE into broader strategies.

• Align with HEOR and Medical Strategy teams on evidence planning and prioritization efforts across therapeutic areas/indications/assets, ensuring alignment with strategic objectives and portfolio needs.

• Guide the evaluation, acquisition, and use of real-world data sources (e.g., EMR, claims, registries, digital biomarkers) for fit-for-purpose use.

• Lead the design and deployment of scalable analytics platforms and data visualization tools that enable rapid, transparent HEOR and Medical Affairs insight generation and decision-making.

• Represent the organization in key scientific and industry forums (e.g., CFL Industry forum, ICER, ISPOR), contributing to the advancement of HEOR/RWE science.

• Build and manage strategic partnerships with external researchers, data providers, and methodological experts to expand research capabilities and influence.

• Publish and present findings in peer-reviewed journals and scientific forums to enhance the visibility and credibility of the organization’s evidence efforts.

• PhD, MS, or PharmD with specialized training in epidemiology, health economics, outcomes research, data science, or related field.

• 8-10+ years of experience in HEOR, Medical Affairs, leading RWE, patient reported outcomes and economic modelling analytics in the pharmaceutical/biotech industry or consulting.

• Demonstrated success in building and leading scientific governance (protocol review committee, SASS assessment for CFL, SIUU), protocol development, analytics, or evidence teams, particularly in cross-functional, matrixed environments.

• Proven expertise in the design and execution of real-world, patient reported outcomes and economic modelling studies and application of advanced statistical and epidemiologic methodologies.

• Excellent leadership, communication, and stakeholder engagement skills, with the ability to influence and collaborate across multiple organizational levels.

• Experience building or transforming HEOR/Medical Affairs evidence generation capabilities within a global organization.

• Knowledge of US and global HTA, regulatory, and payer expectations related to RWE, PRO and economic modelling.

• Deep understanding and hands-on experience in Patient-Reported Outcomes (PROs), including instrument selection, validation, and integration into evidence generation strategies. Knowledge of relevant regulatory and payer frameworks, including FDA guidance on PRO measures and the Patient-Focused Drug Development (PFDD) initiative.

• Demonstrated expertise in economic modelling methodologies, including Indirect Treatment Comparisons (ITC), Network Meta-Analysis (NMA), and Matching-Adjusted Indirect Comparison (MAIC) to support comparative effectiveness and value demonstration.

• Proficiency in statistical programming languages and tools such as SAS, R, and Python, with a strong understanding of their use in observational research and HEOR and Medical Affairs analytics.

• Experience overseeing or contributing to the development of interactive visualization platforms (e.g., Tableau, R Shiny) to enable real-time data interpretation and cross-functional insights.

• Boston Based Hybrid role

• 15-20% Travel