Senior Director, R&D Data Science & Digital Health, Real-World Evidence (RWE), A
Scorpion Therapeutics, Rancho San Diego
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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