Chiesi Group

Compensation

Full Description

About the position Responsibilities • Strategy and Leadership: • Develop and execute a comprehensive RWE strategy aligned with the company’s mission to advance Phase 3 trials and post-approval studies. • Build the RWE function from its early stages, establishing processes, infrastructure, and a high-performing team. • Act as a thought leader, fostering an entrepreneurial culture that drives innovation and collaboration across departments. • Set the global strategic direction for RWE, ensuring alignment with corporate objectives and influencing board-level investment decisions. • Integration with R&D: • Partner closely with R&D to integrate RWE into Phase 3 trial design, ensuring robust evidence generation for regulatory submissions through external control arms, patient stratification, and endpoint validation. • Identify opportunities to use RWD to optimize trial protocols, patient recruitment, and endpoint selection. • Support post-market surveillance and label expansion through RWE studies. • Market Access and Stakeholder Engagement: • Collaborate with market access teams to generate RWE that demonstrates the clinical value, safety, and effectiveness of therapies to payers, providers, and regulators. • Engage with external stakeholders (e.g., regulatory agencies, healthcare providers, patient advocacy groups) to align RWE outputs with industry needs, enhancing HCP trust and patient acceptance. • Provide medical evidence to support health technology assessments (HTAs) and reimbursement strategies. • Drive global stakeholder alignment, harmonizing diverse regional requirements to ensure RWE supports universal patients’ access to medicines, HCPs’ acceptance and data-enabled shared decision-making. • Digital Innovation and NLP Integration: • Leverage digital technologies and advanced analytics, including NLP, to extract insights from unstructured data sources (e.g., EHRs, social media, patient forums). • Drive the adoption of cutting-edge tools and platforms to enhance data processing, analysis, and visualization. • Partner with digital technology experts to ensure scalable, secure, and compliant data infrastructure for RWE generation. • Team Building and Cross-Functional Collaboration: • Recruit, mentor, and lead a diverse team of data scientists, epidemiologists, and analysts to execute RWE initiatives. • Foster collaboration with cross-functional teams, including clinical development, regulatory affairs, and commercial teams, to ensure seamless integration of RWE insights. • Champion a culture of innovation, encouraging creative problem-solving and agile execution. • Orchestrate cross-franchise collaboration, ensuring RWE strategies integrate seamlessly with the AIR and CARE franchises to address portfolio-wide objectives. • Regulatory and Compliance: • Ensure RWE studies meet regulatory standards (e.g., FDA, EMA guidelines) for use in submissions and decision-making across global markets. • Maintain compliance with data privacy regulations (e.g., HIPAA, GDPR) and ethical standards in RWD utilization. Requirements • Advanced degree (PhD, MD, or equivalent) in epidemiology, health economics, data science, or a related field. • 10+ years of experience in RWE, health outcomes research, or related fields, with at least 5 years in a leadership role. • Proven track record of building and scaling RWE programs, ideally in a biotech or pharmaceutical setting. • Deep understanding of Phase 3, 3b, and 4 trial design, regulatory requirements, and market access strategies. • Expertise in digital health technologies and advanced analytics, including NLP, machine learning, or AI-driven data analysis. • Entrepreneurial mindset with a passion for innovation and the ability to thrive in a dynamic, fast-paced environment. • Exceptional leadership and communication skills, with experience managing cross-functional teams and external partnerships. • Familiarity with RWD sources (e.g., EHRs, claims data, registries) and analytical tools (e.g., Python, R, SQL). Nice-to-haves • Experience working with regulatory agencies (e.g., FDA, EMA) on RWE submissions. • Knowledge of health policy, payer dynamics, and HTA processes. • Comfort with ambiguity and a proactive approach to building processes from the ground up. • Strong network within the biotech/pharma industry and RWE community. Benefits • We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. • Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. • Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.