Clinical Program Leader
Chiesi | |
United States, North Carolina, Cary | |
175 Regency Woods Place (Show on map) | |
April 29, 2024 | |
About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years' experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group research, develops and markets innovative drugs in its three therapeutic areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support special care and consumer-facing self-care). Chiesi USA Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work. What we offer Chiesi offers competitive benefits, services, and programs that enrich the personal and professional lives of our employees. Our shared values of passion, innovation, trust and integrity bring out the individual talents and diverse perspectives of each of our colleagues. Our environment encourages each individual to reach his or her full potential and drive outstanding results. We celebrate that "Every one of us is different. Every one of us is Chiesi." Purpose
The CPL is a permanent member of the cross-functional R&D global Core Team (CT) who plays a key role in defining the target disease profile (TDP), target product profile (TPP), and the development and life cycle strategies of a given project. The CPL leads the Clinical Development Plan (CDP) Team (which consists of functional leaders from within GCD e.g.: Clin Pharm, Clin Ops, Biostat, etc.) in the design and execution of the clinical development pan (CDP) from Phase I-IV world-wide. The CPL is the senior Clinical Signatory on all clinical documents related to his/her project such as phase I-IV study protocols, the Investigator's Brochure, the Risk Assessment & Mitigation Plan, publications, and is responsible for all clinical aspects related to the Clinical Trial Dossier (clinical modules, briefing books, scientific advice, meetings with regulatory agencies, etc.) and is the main clinical contact with external though leaders, professional societies and patient advocacy groups. The CPL serves as the principal internal clinical resource for R&D concerning the disease area and project, working with other members of the Core Team to raise disease awareness and product knowledge levels within Chiesi. At Chiesi, CPLs may also serve as Clinical Research Physicians on select phase I-IV studies, where needed. Not all CRPs are designated CPLs. Main Responsibilities
* Develops the TPP and the Clinical Development strategy as a member of the Core Team and with input from the CDP team Experience Required
Education
* Medical Doctor Degree; certification in Respiratory Diseases/Pulmonology will represent a plus Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one's employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination. |