Real World Evidence Lead Pharmacoepidemiologist

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with 90 years’ experience, operating in 31 countries with more than 7,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas: Discover more here

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 a transparent and ethical behavior at all levels.

We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.

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 Research & Development

Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China).

Who we are looking for

Purpose

As direct report of the Head of RWE, you will apply your pharmaco-epidemiological expertise to:

1) develop and lead assigned project RWE Strategy & Tactical plans and design fit for purpose RWE studies -both regulatory and non-regulatory- aimed at advancing disease knowledge, patient care and value proposition of corporate brands, in line with Chiesi strategic goals and medical/scientific standards;

2) act as subject matter expert on pharmaco-epidemiological methods and approaches across multiple RWE company projects

Main Responsibilities

• For the assigned project/product, consistently with the Global project strategy and in alignment and collaboration with the relevant cross-functional teams:

- Critically appraise existing epidemiology evidence and create new evidence through delivery of specific research questions/protocols and analysis of healthcare databases

- Conceive and design epidemiological studies aimed at improving disease understanding relevant to TPP definition and product development: incidence, prevalence, risk factors, natural history course, treatment patterns, co-morbidities, co-medications, outcome measures, phenotypes, biomarkers, unmet needs, and their variations across domains such as demographics and geographies

- Lead the definition of the RWE part of the Global Clinical Development Plan, both pre-approval and post approval (e.g. PASS).

- Identify RWE approaches to optimize clinical development during study design (e.g. synthetic arms, pragmatic trials, hybrid trials, etc) and execution (e.g. RWE approaches for protocol feasibility assessment, site/physicians identification, etc).

- Contribute to the Evidence Generation Plans to build the project/product value proposition, by designing observational studies, epidemiological studies, retrospective and prospective clinical registries, large electronic medical administrative registries

- Perform feasibility assessments and identify of fit-for-purpose data for RWE research

- Develop and negotiate RWE research plans with external collaborators in academia or contract research organizations and work effectively with vendors for outsourced studies, based on both primary and secondary data collection, or hybrid approaches, including research question/protocol development and analysis specification following best methodological standards.

- Drive the interpretation of analysis in collaboration with the cross-functional team and communicating analysis interpretation internally and externally.

- Contribute to publication and dissemination of pharmacoepidemiology studies.

• As pharmacoepidemiology subject matter expert:

- Collaborate with Scientific Societies on Disease Registries, to maximise the value extraction from their development and interrogation

- Provide critical appraisal of observational studies and study protocols across the company

- Support and advice scientifically and from a methodological point of view on Real World Evidence strategies across multiple projects, as subject matter expert

- Masters Pharmacoepidemiology/RWE science and expertise by continuous learning training and working

- Interact and contribute to functional, cross-functional, company-wide or external Pharmacoepidemiology/RWE communities, networks, collaborations, initiatives or goals on knowledge-sharing, methodologies, innovations, technology, regulatory, processes, etc.

Experience Required

Minimum 8-year experience in epidemiology, pharmacoepidemiology, non-interventional studies (prospective studies, patient registries, retrospective database studies), RWE generation in biopharmaceutical industry or CROs

Education

MSc in Health Science disciplines (Medicine, Veterinary, Biology, Biotechnology, Pharmacy) combined with PhD in Epidemiology/Pharmacoepidemiology/Public Health/Outcomes Research

Languages

English fluent

Technical Skills

- Solid knowledge of team-based drug development process, including regulatory interaction with competent Authorities

- Solid knowledge of epidemiological/pharmaco-epidemiological science and methodology

- Ability to discern strengths and limitations of large real-world datasets — such as electronic health records, claims, clinical data registries, patient-generated health data, and other health data sources — in the context of designing epidemiology studies

- Successfully deliver global RWE/pharmacoepidemiology projects from conceptualisation to publication within the pharmaceutical industry (or with a recognised expert consultancy or academic centre of excellence), using primary as well as secondary data, such as large healthcare databases, administrative registries, health economics and outcome research (HEOR).

- Background knowledge of industry trends and best practices, specifically related to epidemiology/RWE/Outcome Research

- Good knowledge and understanding of applicable regulations in pharmacoepidemiology, pharmacovigilance, clinical development, GCP.

- Good understanding of biostatistics

- Expertise in the EU5 and/or US healthcare environment

- Proven ability to write/edit scientific communications (research questions, protocols, abstracts, poster presentations, podium presentations, manuscripts, etc.)

- Expertise in Respiratory Area and Asian environment represent a plus

Soft Skills

• Emotional and social intelligence
• Goal orientation
• Learning agility
• Team working
• Strategic thinking

What we offer

You would join a dynamic, fast-growing, challenging and friendly environment.

In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.

We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.