Who we are looking for
Purpose
The Senior Clinical Research Physician provides scientific and strategic leadership in the design, execution, and interpretation of global clinical studies in the non-obstructive respiratory diseases therapeutic area.
They will drive the preparation of documents for regulatory submissions, ensuring the scientific validity and rigor of key documents, including study protocols, investigator brochures, and clinical study reports.
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
• Enhances clinical study execution, working cross-functionally with internal stakeholders and the Clinical team to uphold medical and scientific integrity across clinical trials.
• Drive 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
• Responsible for the clinical interpretation of study data and communication to internal and external stakeholders
• 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
• Represents the company in front of health authorities, regulatory agencies, external partners, and scientific institutions, contributing to regulatory discussions and ensuring alignment with Global Clinical Development objectives.
• 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.
• Be delegated to replace CPL or be assigned as CPL for some specific phase of the clinical programs
• Provide medical and scientific inputs in RWE studies/ disease registries
Experience Required
At least 5 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.
Experience within the specific therapeutic area (Interstitial Lung Disease; Pulmonary Hypertension) and experience in pharmaceutical /biotech industry are preferred and will be a plus.
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.
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.