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Associate Director, Real World Evidence - AIR

Date : Feb 25, 2025

Department : Medical Affairs

Job Type : Direct Employee

Team : R&D, Pharmacovigilance & Regulatory Affairs

Contract Type : Permanent

Location : Cary, NC, US

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group research, develops and markets innovative drugs in its three therapeutic areas : AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CAR E (products and services that support special care and consumer-facing self-care).

We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification , a recognition of high social and environmental standards. We are a reliable company that adopts and promotes transparent ethical behavior at all levels.

We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

Chiesi USA

Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp™ and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work.

At Chiesi, we share an entrepreneurial spirit and act as a force for good, pursuing high social and environmental standards, to ensure the wellbeing of our people, patients, and communities. We offer a work environment where professionals have the opportunity to build a purposeful career focused on helping others while achieving a fulfilling work-life balance, meeting exciting challenges, and engaging in important and rewarding work.

What we offer

Chiesi offers competitive benefits, services, and programs that enrich the personal and professional lives of our employees. Our shared values of passion, innovation, trust and integrity bring out the individual talents and diverse perspectives of each of our colleagues. Our environment encourages each individual to reach his or her full potential and drive outstanding results. We celebrate that “Every one of us is different. Every one of us is Chiesi."

Who we are looking for

Purpose

The Associate Director, RWE - AIR is a scientific role will collaborate with and support a diverse set of analyses across the portfolio of Chiesi USA AIR medicines by developing advanced, strategic real-world data capabilities and the methodologies to support them. In the role, the Associate Director will have the opportunity to do this work in a vibrant medical affairs research environment, with a strong innovative culture, and a cross matrix organization committed to research supporting HCPs, population decision makers and policy makers.

Main Responsibilities

Leading RWE study design, protocol development, specification, analysis, execution.

Liaising with RWE Methodologists internally and externally concerning study design and RWD Specialists concerning choice of data source on an as needed basis.

Conducting and collaborating with RWE vendors and contractors on literature reviews, analytical projects, and report creation

Driving interpretation of analysis in collaboration with medical affairs leaders, scientists and internal stakeholders; communicating analysis interpretation internally and externally.

Deliver innovative self-service analytics solution and tools to enable broad business users to leverage large real-world data and advanced analytics for external use.

Experience Required

Five years of relevant experience (e.g., academia, consulting, and / or industry); a minimum of five years in the pharmaceutical / biotechnology / vaccine industry.

Demonstrated track record of leading and executing multiple research projects with no or minimal supervision using real-world data from claims, electronic health records, registries, biobanks, and / or digital applications.

Demonstrated success with implementing post-market studies and a strong understanding of study initiation and management at the operational level.

Comprehensive understanding of the pharmaceutical industry and regulatory environment concerning post-licensure commitments, including 21st Century Cures and HECI.

Demonstrated ability to build credible professional relations with key opinion leaders / external experts to enhance design, study enrollment (where appropriate) and publication plans.

Well-developed conceptual and integrative thinking with capability to access internal and external resources for advice.

Demonstrated proficiency in more than one research methodology (ie. claims analysis, real world evidence, cost effectiveness, epidemiology, meta-analysis, indirect treatment comparisons).

Demonstrated ability to publish study results in peer-reviewed journals and present those results at scientific conferences.

Ability to travel up to 25%, including international travel.

Education

Advanced degree (e.g., PhD, PharmD, DrPH, or MD) in an RWE-related field (e.g., epidemiology, outcomes research, health services research, health economics, health policy). A clinical background should be supplemented with advanced quantitative training in data science, biomedical informatics, health informatics, clinical informatics, epidemiology, biostatistics, health economics and outcomes research, engineering or a related field required.

Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one’s employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.

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