Date:6 Feb 2025 Department:GRD Clinical Development Team:R&D, Pharmacovigilance & Regulatory Affairs Job Type:Direct Employee Contract Type:Permanent Location:Parma, IT _About us_ - Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 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 - Leads and manages the Patient Engagement Unit in GRD Clinical Development - Represent the voice of patients and educate on the patient’s point of view within Chiesi GRD R&D - Lead the global patient engagement strategy of the assigned GRD R&D programs across the clinical development pipeline chain - Build, promote and maintain partnership with key internal stakeholders, such as Patient Advocacy, Clinical Operations, Clinical Development, and Medical Affairs - Build, promote and maintain partnership with key external stakeholders, such as Key Opinion Leaders, patients’ associations and groups, and international consortia - Active member of the Clinical Development Leadership Team Main Responsibilities - Line management responsibilities for the GRD Patient Engagement team - Act as Subject Matter Expert for any patient-related aspects concerned with the assigned projects/programs and clinical studies - Consult with patient experts and/or patient associations and groups to understand the burden of clinical research participation in collaboration with the Patient Advocacy Team - Contribute to the production of the Target Product Profile, clinical development plan, or other regulatory documents for the assigned projects/programs - Contribute to the production of clinical study documents (e.g. protocol, participant information sheet and consent form, participant facing material, operational plans) - Manage patient recruitment and retention strategies in collaboration with the Clinical Operations group - Contribute to the overall clinical operation strategy (including recruitment and retention) for the assigned clinical studies in collaboration with the Clinical Operations Team - Lead and/or participate in internal and external projects and initiatives dedicated to foster patient-centred clinical study design and clinical research in general - Coordinate or contribute to the development of patient-centred clinical outcome assessments by consulting patient experts, patient associations and groups and collaborating with CD and MA teams - Design and develop patient-centred clinical studies (e.g. patient experience data, observational study, registries) in collaboration with Clinical Development and Medical Affairs teams - Provide oversight of vendors and providers - Accountable for budget planning and management activities for GRD R&D Patient Engagement Department - Act as Coordinator for the Clinical Trial Transparency Initiative - Act as GRD Subject Matter Expert for Clinical Trial Decentralization - Member of Extended Clinical team and of the clinical study team for assigned GRD R&D programs and studies Experience Required - At least 3 years of significant experience in the field, as defined by one or