Chiesi USA, Inc.
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Vice President, Real World Evidence
role at
Chiesi USA, Inc.
Chiesi Global Rare Diseases is a Chiesi Group business unit established in February 2020, focused on research, development, and commercialization of treatments and patient support services for rare and ultra‑rare disorders. The unit, based in Boston, Massachusetts, works closely with the headquarters in Parma and partners with global leaders in scientific research, patient advocacy, and care.
Who We Are Looking For The Global Medical VP of Real‑World Evidence will be a visionary leader responsible for building and scaling our RWE function, shaping the strategy from the ground up. This role combines scientific rigor, digital innovation, and entrepreneurial drive to harness real‑world data for regulatory submissions, market access, and optimized patient outcomes.
This is What You Will Do
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.
You Will Need To Have
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).
We Would Prefer For You To Have
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.
Location This is a hybrid position based in our Boston, MA office.
Compensation The annual base pay for this position ranges from $311,850 to $381,150. Hourly and salaried non‑exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job‑related knowledge, skills, and experience. If hired, the employee will be in an “at‑will” position and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
What We Offer No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in a dynamic, friendly environment with access to resources and training every step of the way. 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.
Chiesi USA is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, marital status, veteran status, or any other basis protected by local, state or federal law. This policy applies to all aspects of one’s employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.
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Vice President, Real World Evidence
role at
Chiesi USA, Inc.
Chiesi Global Rare Diseases is a Chiesi Group business unit established in February 2020, focused on research, development, and commercialization of treatments and patient support services for rare and ultra‑rare disorders. The unit, based in Boston, Massachusetts, works closely with the headquarters in Parma and partners with global leaders in scientific research, patient advocacy, and care.
Who We Are Looking For The Global Medical VP of Real‑World Evidence will be a visionary leader responsible for building and scaling our RWE function, shaping the strategy from the ground up. This role combines scientific rigor, digital innovation, and entrepreneurial drive to harness real‑world data for regulatory submissions, market access, and optimized patient outcomes.
This is What You Will Do
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.
You Will Need To Have
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).
We Would Prefer For You To Have
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.
Location This is a hybrid position based in our Boston, MA office.
Compensation The annual base pay for this position ranges from $311,850 to $381,150. Hourly and salaried non‑exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job‑related knowledge, skills, and experience. If hired, the employee will be in an “at‑will” position and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
What We Offer No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in a dynamic, friendly environment with access to resources and training every step of the way. 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.
Chiesi USA is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, marital status, veteran status, or any other basis protected by local, state or federal law. This policy applies to all aspects of one’s employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.
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