Clinical Pharmacologist Lead

Join to apply for the Clinical Pharmacologist Lead role at Chiesi Group 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:
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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  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).This

is what you will doLead clinical pharmacology science for the assigned Clinical Development Programs, incorporating quality pharmacokinetics and pharmacodynamic analysis

Contribute to the development and application of clinical trial methodologies across projects in order to devise and optimize future studies

Work with other members of the pre‑clinical and clinical development matrix to steer clinical pharmacology study science and integrate appropriate PK/PD modelling and simulation strategies

Drive clinical pharmacology strategy across assets ensuring alignment with pharmacometrics, translational and precision medicine, bioanalytical, and biomarker assessments to increase confidence in the right dose, patient, and target

Keep abreast of developments in the field of clinical pharmacology, PK/PD, and ensure colleagues are kept up‑to‑date with relevant information according to the type of therapeutics and the disease area

You will be responsible forActs as leader of the Early First In Human (FIH) Study Team, delivering the execution plan for FIH trials through interaction with other functions on pre-nominated products

Acts as a member of Clinical Development Plan Teams and/or Core Teams and/or Clinical Study Teams according to the governance

Responsible for the design of the outlines relative to the assigned Project Development Plan(s) and for securing timely and quality execution of the plan through interactions

Provides expert input to the design of the Clinical Pharmacology protocols relative to the assigned Project Development Plan(s)
Ensures application of enhanced, up to date trial designs by partnering with all relevant disciplines, as well as of Company standards, SOPs and achievement of agreed KPIsIn cooperation with the study team, understands and interrogates data. Works on Statistical Analysis Plan with the statistician and interprets statistical analysis results

Be responsible to plan and perform the population PK and PK/PD analyses (safety and efficacy) on a continuous and live basis as the project progresses

In collaboration with study team and modeling and simulation experts plan and implement Model Informed Drug Development approaches to inform decision making and optimise clinical development,…