Senior Director, R&D Data Science & Digital Health, Real-World Evidence (RWE), A
Scorpion Therapeutics, Rancho Santa Fe, California, United States
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Role Summary Senior Director leading Real-World Evidence (RWE) strategy across therapeutic areas for Johnson & Johnson Innovative Medicine. Drive regulatory-grade evidence generation, cross-functional collaborations, and external thought leadership to shape the RWE ecosystem. Partner with senior leaders across R&D and commercial to build an integrated, agile program that informs clinical development and regulatory decision-making while elevating scientific leadership.
Responsibilities
Strategic Leadership & Ecosystem Building
Define and execute the RWE initiatives across therapeutic areas, ensuring alignment with long-term organizational goals
Lead cross-functional RWE committees and foster high-impact partnerships with internal and external stakeholders
Shape and elevate the enterprise-wide RWE ecosystem through innovation, governance, and capability building
Regulatory Policy & Scientific Influence
Serve as a strategic advisor on regulatory-grade evidence generation and policy shaping
Lead preparation and presentation of scientific data packages for regulatory submissions and agency interactions
Represent J&J in external forums to influence RWE standards and regulatory expectations
Scientific Leadership & Methodological Excellence
Chair the Methodology Review Board (MRB) and oversee a portfolio of high-impact RWE projects
Establish best practices for novel study designs and implementation
Promote continuous learning and innovation in emerging RWE methodologies and technologies
Develop frameworks and tools to scale evidence generation and accelerate delivery
Champion a culture of scientific rigor, collaboration, and execution excellence
Qualifications
Required: Ph.D. or Master's in epidemiology, biostatistics, outcomes research, health policy, or related field
Required: 10+ years of relevant experience in biopharma, RWE consulting, or healthcare industries
Required: 7+ years of experience as a people manager
Required: Proven expertise in data extraction, cleaning, and analysis; strong grasp of advanced statistical methods
Required: Experience with diverse data sources (EHR, claims, registries, trial data, digital health)
Required: Strong communication skills with the ability to engage both technical and non-technical stakeholders
Required: Proven leadership and influencing capabilities, with a track record of inspiring teams and driving cross-functional alignment
Required: Highly motivated and intellectually curious, with strong executional rigor
Required: Proficiency in R, Python, or SQL
Preferred: Expertise in regulatory-grade evidence generation and regulatory engagement
Preferred: Strong leadership in cross-functional initiatives and ability to influence without authority
Preferred: Subject matter expertise in Oncology, Immunology, Neuroscience
Preferred: Experience in matrixed organizations and global stakeholder engagement
Skills
Data analysis and statistical methods for real-world evidence
Regulatory engagement and communicating with agencies
Cross-functional leadership and stakeholder management
Strategic planning and ecosystem development
Proficiency in R, Python, SQL
Education
Ph.D. or Master's in epidemiology, biostatistics, outcomes research, health policy, or related field
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Role Summary Senior Director leading Real-World Evidence (RWE) strategy across therapeutic areas for Johnson & Johnson Innovative Medicine. Drive regulatory-grade evidence generation, cross-functional collaborations, and external thought leadership to shape the RWE ecosystem. Partner with senior leaders across R&D and commercial to build an integrated, agile program that informs clinical development and regulatory decision-making while elevating scientific leadership.
Responsibilities
Strategic Leadership & Ecosystem Building
Define and execute the RWE initiatives across therapeutic areas, ensuring alignment with long-term organizational goals
Lead cross-functional RWE committees and foster high-impact partnerships with internal and external stakeholders
Shape and elevate the enterprise-wide RWE ecosystem through innovation, governance, and capability building
Regulatory Policy & Scientific Influence
Serve as a strategic advisor on regulatory-grade evidence generation and policy shaping
Lead preparation and presentation of scientific data packages for regulatory submissions and agency interactions
Represent J&J in external forums to influence RWE standards and regulatory expectations
Scientific Leadership & Methodological Excellence
Chair the Methodology Review Board (MRB) and oversee a portfolio of high-impact RWE projects
Establish best practices for novel study designs and implementation
Promote continuous learning and innovation in emerging RWE methodologies and technologies
Develop frameworks and tools to scale evidence generation and accelerate delivery
Champion a culture of scientific rigor, collaboration, and execution excellence
Qualifications
Required: Ph.D. or Master's in epidemiology, biostatistics, outcomes research, health policy, or related field
Required: 10+ years of relevant experience in biopharma, RWE consulting, or healthcare industries
Required: 7+ years of experience as a people manager
Required: Proven expertise in data extraction, cleaning, and analysis; strong grasp of advanced statistical methods
Required: Experience with diverse data sources (EHR, claims, registries, trial data, digital health)
Required: Strong communication skills with the ability to engage both technical and non-technical stakeholders
Required: Proven leadership and influencing capabilities, with a track record of inspiring teams and driving cross-functional alignment
Required: Highly motivated and intellectually curious, with strong executional rigor
Required: Proficiency in R, Python, or SQL
Preferred: Expertise in regulatory-grade evidence generation and regulatory engagement
Preferred: Strong leadership in cross-functional initiatives and ability to influence without authority
Preferred: Subject matter expertise in Oncology, Immunology, Neuroscience
Preferred: Experience in matrixed organizations and global stakeholder engagement
Skills
Data analysis and statistical methods for real-world evidence
Regulatory engagement and communicating with agencies
Cross-functional leadership and stakeholder management
Strategic planning and ecosystem development
Proficiency in R, Python, SQL
Education
Ph.D. or Master's in epidemiology, biostatistics, outcomes research, health policy, or related field
#J-18808-Ljbffr