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About us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical 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 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, chemical manufacturing and controls, 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) and Toronto (Canada).
Who we are looking for
Purpose
* Lead clinical pharmacology science for the assigned Clinical Development Programmes, incorporating quality pharmacokinetics and pharmacodynamic analysis, and utilizing internal and literature data.
* Work with other members of the pre-clinical and clinical development matrix to steer clinical pharmacology study science and integrate appropriate PK/PD modeling and simulation strategies across a defined therapeutic area.
Main Responsibilities
* Acting as a member of Extended Clinical Team and/or Clinical Study Team, in cooperation with other Study Team Members, delivers results of the assigned Clinical Studies and related Key Clinical Documents, in accordance with the Clinical Development Plan and the related agreed timelines (e.g. Clinical pharmacology section of the investigator's Brochure, Clinical pharmacology section of the Investigational Medical Product Dossier, Writing & Publication of data from assigned Clinical Studies,…).
* Ensures application of Company standards, SOPs and achievement of agreed KPIs
* In cooperation with the study team, gets inside the data, understands and interrogates it, masters the art of deriving an understanding of individual subject response, works with the statistician on Statistical Analysis Plan, defines, prioritizes and interprets statistical analyses, defines total risk-benefit profile, interprets data in relation to program (i.e. in the context of the totality of the data) and external competitors.
* Provides expert input to the design of the Clinical Pharmacology protocols relative to the assigned Project Development Plan(s), being responsible for the design of the outlines, for securing timely and quality execution of the plan through interaction
* Consults CPL and Head of the GCD Unit to discuss emerging data and, anticipating trends, identifies new clinical opportunities for product growth, proposing options to CPL.
Experience Required
At least 2 years' experience in the role gained either in pharmaceutical, biotechnology Company or CRO
Education
Scientific degree or PhD
Languages
English Fluent
Technical Skills
Basic Clinical pharmacology experience including knowledge of the design of phase I clinical pharmacology studies.
Excellent understanding of the drug development process.
Soft Skills
* Goal orientation
* Leadership and social influence
* Quality orientation
* Team working
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.
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