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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 have been awarded with 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.
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 Global Rare Diseases
Chiesi Global Rare Diseases is a Chiesi Group’s business unit established in February 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available.
This unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma.
Rare unit has a focus on research and product development for lysosomal storage diseases, rare hematology, ophthalmology disorders and rare immunodeficiencies. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care. Discover more here.
What we are looking for
Purpose
• Lead 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 modeling and simulation strategies
• Work in collaboration with Modeling and Simulation experts to provide guidance on optimal PK and PK/PD sampling for implementation in the various stages of development
• 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
Main Responsibilities
• Acts 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 KPIs
• In 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 optimize clinical development, including Modeling Analysis Plan and Report, Data Specification document for data analysis and the definition of model impact and risk
• Evaluate the potential use of different technologies and approaches to support project progression, e.g. empirical approach, Quantitative System Pharmacology, sparse methodology
• Interprets study results in relation to program (i.e. in the context of the totality of the data) and external competitors and contribute to defining the total risk-benefit profile of the assigned product(s) (probability of pharmacological success)
• Delivery of results of the assigned Clinical Studies and related Key Clinical Documents, in accordance with the Clinical Development Plan and the related agreed timelines
• Prepares and review Clin Pharm sections for Briefing books, IB, IMPD, Clinical development Plans, and Clinical Pharmacology Study protocols & Reports
• Writing & Publication of data from assigned Clinical Studies according to the agreed publication plan, acting as Clinical Pharmacology Subject Matter Expert in the assigned product(s)
• Prepares and review the relevant CTD sessions including interaction with authorities and answering to regulatory questions
• contributes, if appropriate, to design of post-registration clinical studies to secure growth of the brand into the marketplace in line with the Lifecycle Management Plan and relative Clinical Development Plan
• Management of the interactions with internal stakeholders (e.g. GRA, etc) and external Key Opinion Leader/ Investigator
• Management of the interaction with external CRO and consultants to support the Clinical Pharmacology and/or Modeling and simulation activities
• Consults the Clinical Program Lead and Head of the Clinical Programs and/or Head of Global Rare Disease Clinical Development to discuss emerging data and, anticipating trends, identifies new clinical opportunities for product growth
Experience Required
5+ years of experience as clinical pharmacologist preferably in industry.
Relevant experience for the role:
• Experience in implementing Model Informed Drug Development (MIDD) strategy for novel biotherapeutics in rare disease area
• Experience in reviewing or approving Clinical Pharmacology Study protocols and reports, Statistical and Modeling Analysis Plan, Pharmacometrics reports and related sections of regulatory documents
• Experience in evaluating and implementing new quantitative tools or technologies as Quantitative System Pharmacology models for a portfolio of products or highly complex projects with broad scope and impact.
Education
MD or PhD or equivalent.
Previous experience in Rare Diseases and/or in the development of biologics and/or advanced therapy (e.g. gene therapy) is desirable.
Languages
Fluency in english
Soft Skills
* Goal orientation
* Planning and organizational skills
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 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.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Research
* Industries
Pharmaceutical Manufacturing
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