Clinical Research Physician

Reports into: Therapeutic Area Head – Respiratory Unit, Global Clinical Development

Department: Global R&D

Location: Europe / Remote

Opportunity to join a dynamic and dedicated Global Clinical Development team committed to advancing therapies for patients across a broad spectrum of respiratory diseases.

About us:
Headquartered in Parma, Italy, Chiesi Group is an international research-focused pharmaceuticals and healthcare group with over 85 years of experience, operating in over 30 countries with more than 7,000 employees. We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. 

Role Description:
The Clinical Research Physician (CRP) plays a key role in the medical oversight of Phase 1 to 3 clinical trials in Respiratory within Global Clinical Development. They ensure scientific and
medical integrity in the development and execution of clinical studies, contributing to the overall clinical strategy and regulatory submissions.

They are able to work comfortably in a matrix environment and is an integral member of the cross-functional clinical study team. They use therapeutic expertise to ensure incorporation of robust scientific principles into study design and conduct and to enhance competencies across R&D.

Main Responsibilities:

• Provide medical and scientific input into clinical trial design and execution in accordance with the Clinical Development Plan and related key clinical documentation (e.g. clinical section of the Investigator’s Brochure, Protocols and Clinical Study Reports).
• Conduct ongoing medical and scientific review of clinical trial data, ensuring data integrity, patient safety and the ongoing benefit-risk assessment.
• Be responsible for the clinical interpretation of study data and communication to internal and external stakeholders.
• Collaborate with Clinical Program Leaders, statisticians, regulatory affairs, and other key functions to drive clinical development plans and contributes to regulatory submission documentation.
• Engage with external experts, regulatory bodies, ethics committees, investigators, and safety monitoring committees to ensure alignment with scientific and medical needs.

Experience Required:
At least 3 years in the pharmaceutical industry preferred although equivalent expertise in clinical or academic research will be considered, preferably within the Respiratory or Allergy & Immunology therapeutic areas.

Education: 
Medical Doctor Degree from a recognised institution; certification in Pulmonary or Allergy & Immunology considered an advantage.

Languages:
Fluency in spoken and written English.

Technical Skills:

• Excellent writing skills in order to effectively contribute to study documentation and reports.
• Outstanding communication skills with ability to interact with all 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.