Clinical Program Leader

**Date**: 22 Apr 2024
**Department**: Global 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 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 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, different 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, chemical manufacturing and controls, 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) and Toronto (Canada).

Who we are looking for

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 thought 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.

Main Responsibilities
- Develops the TPP and the Clinical Development strategy as a member of the Core Team and with input from the CDP team
- Coordinates alignment and agreement on CDP matters with the CDP Team, Core Team and GCD-LT
- Ensures that the design of each clinical study is consistent with the CDP
- Ensures that the CDP is in line with the approval path agreed with Regulatory Agencies and with the agreed business plan & objectives
- Provides clinical approval (protocols, CSRs, lay summaries, clinical trial disclosure &/or deferral strategy, data sharing requests)
- As part of the Submission Team, prepare/review Briefing Books, eCTD modules, represent clinical aspects during interaction with Regulatory Authorities
- Regularly updates the CDP team all aspects discussed at Core Team or internal bodies
- Secures necessary internal approvals & external endorsement (e.g. disease area experts, consultants) to the CDP elements
- Ensuring accurate & timely documentation of all actions and decisions related to the CDP.

Experience Required

A 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 asthma therapeutic area is a plus.

Education

Medical Doctor Degree; certification in Respiratory Diseases/Pulmonology will represent a plus

Languages

English fluent

Technical Skills
- Proficiency in reading, interpreting, and evaluating regulatory guidance documents and initiating changes in systems to ensure regulatory compliance
- Dem