Clinical Research Physician

Reports into: Senior Director, TA Head Non-obstructive Respiratory Diseases, Global Clinical Development AIR

Department: Global Research & Development

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 90 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 within our Respiratory Unit in Global Clinical Development. The CRP ensures scientific and medical integrity in the development and execution of clinical studies, contributing to the overall global clinical strategy and regulatory submissions.

CRP are able to work well in a matrix environment and is an integral member of the cross-functional clinical study team, using therapeutic expertise to ensure the 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.
• Ensure the safeguard of Patients Safety: in collaboration with and in support of Corporate Pharmacovigilance identify safety signals, review narratives, take actions with investigators when Serious/unexpected Adverse Events are reported.

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 Immunology therapeutic areas.

Education:
Medical Doctor Degree from a recognised institution; certification in Respiratory or 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.