Clinical Program Leader

Business Area: R&D, Pharmacovigilance & Regulatory Affairs Job Type: Direct Employee Contract Type: Permanent Location: Europe - Remote, IT About us 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 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. In fact, we are a global family made up of different cultures, 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). Who we are looking for Purpose The Clinical Program Leader (CPL) is a core member of the cross‑functional R&D Global Core Team, playing a pivotal role in shaping the global clinical strategy and development for their assigned program. They ensure scientific and medical integrity in the development and execution of clinical studies, leading clinical input into regulatory submissions and interactions. This role requires strong scientific acumen, matrix team leadership, and strategic vision to drive the successful development and commercialization of innovative therapies in alignment with patient needs and global regulatory standards. Main Responsibilities Leads the strategic planning and high-quality execution of clinical development programs, ensuring scientific rigor and alignment with regulatory and business objectives. Provide clinical leadership within the Core Team, ensuring the clinical perspective informs key strategic decisions. Lead the Clinical Team in designing and executing a comprehensive global clinical development strategy from Phase 1 through Phase 4, optimizing study design and execution. Clinical oversight of the design, implementation and operational delivery of clinical studies from early to late-stage drug development. Provides medical and scientific leadership to cross‑functional teams, driving internal disease awareness and enhancing knowledge of the product landscape. Represents the company and clinical program in regulatory authority interactions, governance meetings and external partnerships, engages with external experts and key stakeholders. Drive data‑driven decision‑making by interpreting clinical trial results and integrating findings into program strategy. Engage with regulatory authorities, external experts, and key stakeholders to shape development plans and ensure compliance with global regulatory requirements. Foster innovation and continuous improvement in clinical trial design and execution to enhance patient outcomes and program efficiency. Experience Required Significant experience in designing and executing a comprehensive clinical research & development plan. At least 5 years in an R&D role in the pharmaceutical/biotech industry, or 7-10 yrs in academia with clinical investigator track record. Experience within the specific therapeutic area is considered an advantage. Education Medical Doctor Degree from a renowned institution; certification in Respiratory or Allergy & Immunology considered an advantage. Languages Fluency in spoken and written English. Technical Skills Experience in development of protocols, reports and preparation of global clinical development plans, as well as authoring clinical sections of regulatory documentation. Outstanding communication skills with ability to interact with and influence internal stakeholders and external academic and regulatory experts. Strong understanding of GCP, regulatory requirements, and clinical trial methodologies. Ability to interpret and effectively communicate complex clinical and scientific data, and literature. Ability to successfully manage multiple tasks and resources concurrently while maintaining high attention to detail and responding to rapidly changing priorities. Soft Skills Leadership and social influence Planning and organizational skills Strategic thinking 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 to 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. #J-18808-Ljbffr