RARE DISEASE CLINICAL RESEARCH PHYSICIAN

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 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.
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 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.
The unit is headquartered in Boston, Massachusetts, and has an initial focus on research and product development for lysosomal storage diseases, rare hematology and ophthalmology disorders.
The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care.
Purpose -    Support the clinical team in relevant medical and scientific aspects of the assigned global clinical studies within the global clinical development program  -    Contributes to the risk/benefit assessment of the ongoing clinical trials assigned  -    May act as the primary medical monitor for an assigned clinical study -    Contributes to the production of the Common Technical Document, in terms of validation of scientific documents relevant to the assigned clinical study (e.
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study protocol, investigator’s brochure, clinical study reports) and represents the company in front of health authorities, partners and institutions -    Develops and enhances the management of the clinical trials, working in collaboration with the Clinical Program Leader and other relevant roles and ensures medical and scientific validity of the assigned clinical studies in terms of design, conduct and interpretation.
Main Responsibilities -    Acting as a member of the program meetings and/or Clinical Study Team, in cooperation with other Study Team Members, to support the design, conduct and analysis as well as data interpretation of assigned clinical studies, including the preparation of key relevant clinical documentation, in accordance to the Clinical Development Plan and agreed timelines (e.
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clinical sections of the Investigator’s Brochure, clinical section of the Investigational Medicinal Product Dossier, protocols, protocol’s amendments, clinical study reports) -    Conducting medical and scientific review on the data of the ongoing and completed clinical trial data with the appropriate oversight from the Clinical Program Leader (CPL) -    As a clinical expert, supporting the CPL in interactions with internal and external stakeholders acting as the subject matter expert in the assigned product(s) and relevant disease(s) area, maintaining and enhancing knowledge in relevant technical or therapeutic areas and in global regulations/guidelines.
-    Interfacing a diverse range of scientific external experts (e.
., regulatory, payors, CROs, consultants, investigators) in order to deliver clinical programs and align on business strategy and address patients’ needs -    Identifying potential trends and support internal decision making, securing timely publication of clinical data according to the agreed publication plan.
-    Ensure the development of a robust, optimized, efficient and innovative trial designs, including selection of clinical endpoints, patients populations and medical monitoring strategy, partnering with all relevant disciplines, as well as upholding Company standards, standard operating procedures, and agreed key performance indicators.
-    Support in the design of post-registration clinical studies to secure the growth of the brand according to the life-cycle management of the product and the relative clinical development plan.
Experience Required 2+ years of experience as Clinical Research Physicians/Medical Monitor in Pharmaceutical Companies or Clinical Research Organizations     Relevant experience in clinical or academic research in rare diseases or     Experience in Clinical Development (clinical trial design, conduct and interpretation) Education Medical Doctor Degree is required;  Preferred Specializations (not binding), Internal Medicine, Nephrology, Cardiology, Pediatrics, Immunology, Neurology Past experience in Rare Diseases (clinical or in the pharmaceutical field) is desirable Languages English fluent Soft Skills Communication skills Creative/innovative mindset Customer orientation Strategic thinking Leadership and social influence 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.