Clinical Research Physician, Global Rare Diseases

Job description

About us Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here. At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better. 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 This is what you will do 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.g. 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. You will be responsible for 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.g. 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.g., 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. You will need to have Medical Doctor degree 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) We would prefer for you to have Preferred Specializations (not binding), Internal Medicine, Nephrology, Cardiology, Pediatrics, Immunology, Neurology Past experience in Rare Diseases (clinical or in the pharmaceutical field) is desirable Location Europe (flexible) – remote or hybrid Compensation range The package outlined below is based on the role being located in Italy. Where the role is offered in a different country, the applicable salary, bonus and benefits will be aligned to the relevant local market and internal frameworks. Full details of the applicable package will be provided at the appropriate stage of the recruitment process. The minimum salary for this role is €60.000, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations. This role is eligible to participate in an annual bonus scheme, subject to company and individual performance. In addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme, ticket restaurant and more. What we offer No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way. We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive. Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.