Chiesi USA, Inc. · 1 day ago
Vice President, Real World Evidence
Boston, MA
Full-time
Hybrid
Director/Executive
$312K/yr - $381K/yr
10+ years expChiesi USA, Inc. is an international research-focused biopharmaceutical group dedicated to promoting a healthier world. They are seeking a visionary leader for the role of Global Medical VP of Real-World Evidence, responsible for building and scaling the RWE function, shaping strategy to harness real-world data for regulatory submissions and market access.
BiotechnologyMedicalPharmaceutical
Responsibilities
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
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
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
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
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
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
Qualification
Required
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)
Preferred
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
Comprehensive healthcare programs
Work-life balance initiatives
Robust relocation support
Performance bonuses
Flexible working arrangements
Remote work options
Tax assistance services for foreign colleagues
Company
Chiesi USA, Inc.
Chiesi USA is a pharmaceuticals company specializing in pharmaceutical research & development services.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$0MKey Investors
North Carolina Biotechnology Center
2020-08-04Grant· $0M
Leadership Team
Jon Zwinski
Chief Executive Officer - General Manager
Molly Rice
Senior Human Resources Business Partner / Associate Director Human Resources
Recent News
Clinical Trials Arena
2024-05-24
Company data provided by crunchbase